chufangao/CTO huggingface dataset:
Clinical trial NCT04142658: PROACT Xa - A Trial to Determine if Participants With an On-X Aortic Valve Can be Maintained Safely on Apixaban
Official title: A Prospective, Randomized, Active (Warfarin) Controlled, Parallel-arm Clinical Trial to Determine if Participants With an On-X Aortic Valve Can be Maintained Safely and Effectively on Apixaban
Sponsor: Artivion Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Safety
Enrollment: 863.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-05-01
Primary completion date: 2022-12-12
Completion date: 2022-12-12
Clinical trial NCT04997161: Study of SZC and Enhanced Nutrition Advice Compared to SoC in Dialysis Patients With Hyperkalaemia
Official title: An Open-Label, Randomised, Controlled, Parallel-Design, Multicentre, Phase IV Study of Sodium Zirconium Cyclosilicate and Enhanced Nutrition Advice Compared to Standard of Care in Dialysis Patients With Hyperkalaemia (GRAZE)
Acronym: GRAZE
Sponsor: AstraZeneca (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: There is disconnect between dietary guidelines to limit potassium intake in dialysis and clinical practice. The number of unknowns and differences make the results unlikely to be translatable into clinical practice and will not benefit patients.
Enrollment: 3.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-08-17
Primary completion date: 2021-11-17
Completion date: 2021-11-17
Baseline population: The baseline population includes the one participant randomized in this study.
Limitations and caveats: The study was terminated by the sponsor with only 1 participant randomized. There was disconnect between dietary guidelines to limit potassium intake in dialysis and clinical practice.
Plan to share individual participant data: YES
IPD sharing description: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment:~https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
IPD time frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at:~https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
IPD access criteria: When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at:~https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
Clinical trial NCT05276401: Nu-3 Topical Gel for Treatment of Diabetic Foot Ulcer
Official title: A Phase 2a, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Dose Escalating Study to Evaluate the Safety and Tolerability of Topically Applied Bisphosphocin Nu-3 Gel to Clinically Noninfected Chronic Diabetic Foot Ulcers (cDFU)
Sponsor: Lakewood-Amedex Inc (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Request for additional preclinical data.
Enrollment: 3.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-03-11
Primary completion date: 2022-05-18
Completion date: 2022-06-15
Limitations and caveats: Early termination leading to small numbers of subjects analyzed.
Plan to share individual participant data: NO
Clinical trial NCT03269383: Study to Evaluate the Effectiveness of SGB in Preventing Post-op Atrial Fibrillation
Official title: Study for the Evaluation of the Effectiveness of Stellate Ganglion Blockade in Preventing Postoperative Atrial Fibrillation
Sponsor: MaineHealth (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: WITHDRAWN 
Why stopped: Lack of funding and other logistical issues
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-12-31
Primary completion date: 2020-12-31
Completion date: 2021-12-31
Plan to share individual participant data: NO
Clinical trial NCT04218825: REACH: Study to Determine the Aetiology of Chlormethine Gel Induced-skin Drug Reaction in Early Stage Mycosis Fungoides Cutaneous T Cell Lymphoma (MF-CTCL)
Official title: Study to Determine the Aetiology of Chlormethine Gel Induced-skin Drug Reaction in Early Stage Mycosis Fungoides Cutaneous T Cell Lymphoma (MF-CTCL)
Acronym: REACH
Sponsor: European Organisation for Research and Treatment of Cancer - EORTC (NETWORK)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: After an extensive assessment of the study feasibility, it was decided to discontinue the clinical trial due to poor recruitment.
Enrollment: 2.0 (ACTUAL)
Number of arms: 1.0
Start date: 2022-03-29
Primary completion date: 2023-04-04
Completion date: 2023-04-04
Clinical trial NCT03863574: Saroglitazar Magnesium in the Treatment of Non-Alcoholic Steatohepatitis
Official title: A Phase 2, Prospective, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of Saroglitazar Magnesium 2 mg and 4 mg in Patients With Non-alcoholic Steatohepatitis (NASH)
Acronym: EVIDENCES VI
Sponsor: Zydus Therapeutics Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 16.0 (ACTUAL)
Number of arms: 3.0
Start date: 2019-06-12
Primary completion date: 2020-03-20
Completion date: 2020-03-20
Clinical trial NCT04017208: A Study to Assess ASP2713 in Healthy Subjects
Official title: A Phase 1 Single Ascending Intravenous Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ASP2713 in Healthy Subjects
Sponsor: Astellas Pharma Inc (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: A business decision was made to not initiate this study.
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-07-31
Primary completion date: 2020-08-31
Completion date: 2020-08-31
Plan to share individual participant data: NO
IPD sharing description: Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
Clinical trial NCT02471430: Reducing the Residual Reservoir of HIV-1 Infected Cells in Patients Receiving Antiretroviral Therapy
Official title: A Phase I-II Pilot Study to Assess the Safety and Efficacy of Combined Administration With Pegylated Interferon-alpha2a and the Histone Deacetylase Inhibitor (HDACi) Panobinostat for Reducing the Residual Reservoir of HIV-1 Infected Cells in cART-Treated HIV-1 Positive Individuals
Acronym: ACTIVATE
Sponsor: Massachusetts General Hospital (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: COMPLETED 
Enrollment: 17.0 (ACTUAL)
Number of arms: 3.0
Start date: 2016-05-31
Primary completion date: 2022-08-31
Completion date: 2023-12-31
Clinical trial NCT04386252: Phase I-II Trial of Dendritic Cell Vaccine to Prevent COVID-19 in Adults
Official title: Adaptive Phase I-II Clinical Trial of Preventive Vaccine Consisting of Autologous Dendritic Cells Previously Incubated With S-protein From Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2), in Subjects Negative for COVID-19 Infection and Anti-SARS-CoV-2 Antibodies
Sponsor: Aivita Biomedical, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: WITHDRAWN 
Why stopped: The FDA put our protocol on clinical hold and never gave an okay to start, so we decided not to proceed
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2023-01-31
Primary completion date: 2023-06-30
Completion date: 2024-01-31
Clinical trial NCT02457598: Dose Escalation and Dose Expansion Study of Tirabrutinib in Combination With Other Targeted Anti-cancer Therapies in Adults With B-cell Malignancies
Official title: A Phase 1b Dose Escalation and Dose Expansion Study of Tirabrutinib (ONO/GS-4059) in Combination With Other Targeted Anti-cancer Therapies in Subjects With B-cell Malignancies
Sponsor: Gilead Sciences (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: The goal of the study was to improve tolerability while maintaining or increasing efficacy. The results of this study showed no efficacy advantage although the combinations were well tolerated.
Enrollment: 203.0 (ACTUAL)
Number of arms: 5.0
Start date: 2015-06-16
Primary completion date: 2024-09-25
Completion date: 2024-09-25
Plan to share individual participant data: NO
Clinical trial NCT05061771: Nomacopan Therapy in Adult Patients With Bullous Pemphigoid Receiving Adjunct Oral Corticosteroid Therapy (ARREST-BP)
Official title: A Randomized, Part A Partial Blinded and Part B Double Blinded, Placebo-controlled 24-week Clinical Study to Evaluate the Efficacy and Safety of Nomacopan Therapy in Adult Patients With Bullous Pemphigoid Receiving Adjunct Oral Corticosteroid Therapy (ARREST-BP)
Acronym: ARREST-BP
Sponsor: AKARI Therapeutics (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: WITHDRAWN 
Why stopped: Akari has decided to discontinue AK802 study due to strategic resource allocation decisions.
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-05-06
Primary completion date: 2022-08-01
Completion date: 2022-08-01
Plan to share individual participant data: NO
Clinical trial NCT03733119: ONC201 With a Methionine-Restricted Diet in Patients With Metastatic Triple Negative Breast Cancer
Official title: ONC201 With a Methionine-Restricted Diet in Patients With Metastatic Triple Negative Breast Cancer
Sponsor: University of Wisconsin, Madison (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Slow accrual
Enrollment: 4.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-11-13
Primary completion date: 2021-02-13
Completion date: 2021-02-13
Limitations and caveats: Trial was terminated early due to slow accrual, not powered for meaningful results, statistical analysis not completed.
Plan to share individual participant data: NO
Clinical trial NCT04513314: Valproate Alone or in Combination With Quetiapine for Severe COVID-19 Pneumonia With Agitated Delirium
Official title: A Practical, Pilot, Randomized, Controlled Trial of Valproate Alone or in Combination With Quetiapine for Severe COVID-19 Pneumonia With Agitated Delirium
Sponsor: University of Miami (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: WITHDRAWN 
Why stopped: coronavirus omicron variant infection typically not associated with delirium and agitation severely hampered recruitment.
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2023-03-28
Primary completion date: 2023-03-28
Completion date: 2023-03-28
Plan to share individual participant data: NO
Clinical trial NCT04737122: Study of LM-061 in Subjects in Advanced Tumors
Official title: A Phase I, First-in-Human, Open-Label, Dose Escalation Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of LM-061 Tablet in Subjects With Advanced Tumors
Sponsor: LaNova Medicines Limited (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Failure to achieve expected outcomes
Enrollment: 18.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-05-06
Primary completion date: 2022-07-19
Completion date: 2022-12-01
Plan to share individual participant data: NO
Clinical trial NCT05492045: A Study to Evaluate D-1553 in Combination Therapy in Non-Small Cell Lung Cancer
Official title: A Phase 1b/2 Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of D-1553 Combination Therapy in Subjects With KRAS G12C-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Sponsor: InventisBio Co., Ltd (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Adjustment of drug development strategy.
Enrollment: 22.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-09-13
Primary completion date: 2024-06-14
Completion date: 2024-06-14
Plan to share individual participant data: NO
Clinical trial NCT02574455: Trial of Sacituzumab Govitecan in Participants With Refractory/Relapsed Metastatic Triple-Negative Breast Cancer (TNBC)
Official title: An International, Multi-Center, Open-Label, Randomized, Phase III Trial of Sacituzumab Govitecan Versus Treatment of Physician Choice in Patients With Metastatic Triple-Negative Breast Cancer Who Received at Least Two Prior Treatments
Acronym: ASCENT
Sponsor: Gilead Sciences (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 529.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-11-07
Primary completion date: 2020-03-30
Completion date: 2020-12-08
Baseline population: The Intent-to-Treat (ITT) Population included all randomized participants.
Plan to share individual participant data: YES
IPD sharing description: Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at https://www.gileadclinicaltrials.com/transparency-policy/
IPD time frame: 18 months after study completion
IPD access criteria: A secured external environment with username, password, and RSA code.
Clinical trial NCT05641324: A Study of ANV419 Alone or in Combination With Approved Treatments in Patients With Multiple Myeloma (OMNIA-2)
Official title: A Phase 1 Study of ANV419 as Monotherapy, and ANV419 in Combination With Daratumumab or With Lenalidomide Plus Low-Dose Dexamethasone, in Patients With Relapsed or Refractory Multiple Myeloma (OMNIA-2)
Sponsor: Anaveon AG (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: The study was ended due to a lack of recruitment
Enrollment: 4.0 (ACTUAL)
Number of arms: 4.0
Start date: 2023-02-10
Primary completion date: 2023-07-12
Completion date: 2023-07-12
Plan to share individual participant data: NO
Clinical trial NCT03733691: Ph 2 Maintenance Trial: Ixazomib vs Ixazomib-Lenalidomide for MM Patients
Official title: A Phase 2, Open Label, Randomized Trial Evaluating Ixazomib Compared to Ixazomib-Lenalidomide Combination Maintenance Therapy for Frontline Multiple Myeloma Patients
Sponsor: Oncotherapeutics (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Insufficient enrollment
Enrollment: 19.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-03-01
Primary completion date: 2023-10-19
Completion date: 2023-10-19
Plan to share individual participant data: NO
Clinical trial NCT05165394: Study to Evaluate the Efficacy and Safety of Once-Weekly Oral NBI-1065846 in the Treatment of Anhedonia in MDD
Official title: A Randomized, Double-Blind, Placebo-Controlled, Proof-of-Concept Study to Evaluate the Efficacy and Safety of Once-Weekly Oral NBI-1065846 in the Treatment of Anhedonia in Major Depressive Disorder (TERPSIS STUDY)
Acronym: TERPSIS
Sponsor: Neurocrine Biosciences (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 93.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-11-30
Primary completion date: 2023-07-07
Completion date: 2023-09-13
Baseline population: Safety Population: All randomized participants who received at least 1 dose of study drug.
Plan to share individual participant data: NO
Clinical trial NCT05965505: Study of AXT-1003 in Adult Subjects With Relapsed/Refractory Non-Hodgkin Lymphomas
Official title: An Open-Label, Multicenter, Phase I Study of AXT-1003 as a Single Agent in Adult Subjects With Relapsed/Refractory Non-Hodgkin Lymphomas
Sponsor: Axter Therapeutics (Beijing) Co., Ltd (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Due to the adjustment of the protocol and expansion of the indication population, a new clinical trial protocol was submitted to the Health Authority, so the registration was conducted as a new clinical trial and this trial was terminated.
Enrollment: 1.0 (ACTUAL)
Number of arms: 1.0
Start date: 2023-08-11
Primary completion date: 2023-09-05
Completion date: 2023-09-05
Plan to share individual participant data: NO
Clinical trial NCT02538341: Safety and Effectiveness of Live Zoster Vaccine in Anti-Tumor Necrosis Factor (TNF) Users (VERVE Trial)
Official title: Safety and Effectiveness of Live Zoster Vaccine in Anti-TNF Users (VERVE Trial)
Sponsor: University of Alabama at Birmingham (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 617.0 (ACTUAL)
Number of arms: 2.0
Start date: 2016-05-31
Primary completion date: 2019-12-31
Completion date: 2020-12-31
Plan to share individual participant data: YES
Clinical trial NCT04838860: Siltuximab In Siltuximab-RElapsed/REfractory Multicentric CAstleman Disease
Official title: A Phase 2 Study of Intrapatient Siltuximab Dose Escalation in Patients With Idiopathic Multicentric Castleman Disease That Has Progressed After Prior Siltuximab Treatment
Acronym: SISREMCAD
Sponsor: EusaPharma (UK) Limited (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Internal Company Decision
Enrollment: 22.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-03-31
Primary completion date: 2021-04-01
Completion date: 2021-04-01
Plan to share individual participant data: NO
Clinical trial NCT02856503: Effect of High Dose Vitamin D on Cancer Biomarkers and Breast Cancer Tumors
Official title: Phase I/II Study Evaluating Safety and Effects of Preoperative High-Dose Vitamin D on the Receptors, Biomarkers and Pathological Characteristics of High Grade DCIS or Invasive Breast Cancer.
Sponsor: University of Miami (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: WITHDRAWN 
Why stopped: Lack of Funding
Enrollment: 0.0 (ACTUAL)
Number of arms: 4.0
Start date: 2019-01-31
Primary completion date: 2023-01-31
Completion date: 2024-01-31
Plan to share individual participant data: NO
Clinical trial NCT02213887: Study of the Effects of Pantoprazole on Levels of Prescribed Psychiatric Medications
Official title: A Pilot Study to Determine if Pantoprazole Modifies Steady-State Plasma Concentrations of Orally Administered Psychotropic Medications
Acronym: PK-PPI
Sponsor: University of British Columbia (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: WITHDRAWN 
Why stopped: Unable to recruit participants
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2014-09-30
Primary completion date: 2020-11-02
Completion date: 2020-11-02
Clinical trial NCT04388189: Leveraging EEG for Antidepressant Prediction With Duloxetine and Bupropion
Official title: Leveraging EEG for Antidepressant Prediction With Duloxetine and Bupropion (LEAP-DB): A Multicenter, Randomized, Blinded Outcome Study of EEG-guided Treatment With Duloxetine Versus Bupropion in Adults With Major Depressive Disorder
Acronym: LEAP-DB
Sponsor: Alto Neuroscience (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: WITHDRAWN 
Why stopped: No participants enrolled
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-10-15
Primary completion date: 2023-05-30
Completion date: 2023-05-30
Plan to share individual participant data: UNDECIDED
Clinical trial NCT03695250: BMS-986205 and Nivolumab as First or Second Line Therapy in Treating Patients With Liver Cancer
Official title: Phase I/II Trial of BMS-986205 and Nivolumab as First or Second Line Therapy in Hepatocellular Carcinoma
Sponsor: University of California, Davis (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Funding source decision to terminate study.
Enrollment: 8.0 (ACTUAL)
Number of arms: 1.0
Start date: 2018-10-16
Primary completion date: 2020-11-24
Completion date: 2021-03-12
Clinical trial NCT03578198: Rituximab Plus MG4101 Indolent CD20-positive Non-Hodgkin Lymphoma (NHL)
Official title: Phase II Study of Rituximab Plus MG4101 in Patients With Relapsed or Refractory Indolent CD20-positive Non-Hodgkin Lymphoma (NHL)
Acronym: MG4101
Sponsor: Seoul National University Hospital (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Issues in supply of IP
Enrollment: 12.0 (ACTUAL)
Number of arms: 1.0
Start date: 2018-11-08
Primary completion date: 2022-04-07
Completion date: 2022-04-07
Plan to share individual participant data: NO
Clinical trial NCT00265941: Radiation Therapy and Cisplatin With or Without Cetuximab in Treating Patients With Stage III or Stage IV Head and Neck Cancer
Official title: A Randomized Phase III Trial of Concurrent Accelerated Radiation and Cisplatin Versus Concurrent Accelerated Radiation, Cisplatin, and Cetuximab (C225) [Followed by Surgery for Selected Patients] for Stage III and IV Head and Neck Carcinomas
Sponsor: Radiation Therapy Oncology Group (NETWORK)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 940.0 (ACTUAL)
Number of arms: 2.0
Start date: 2005-11-30
Primary completion date: 2011-01-31
Completion date: 2022-05-20
Baseline population: Eligible patients with follow-up
Clinical trial NCT03783442: A Study of Tislelizumab (BGB-A317) in Combination With Chemotherapy as First Line Treatment in Participants With Advanced Esophageal Squamous Cell Carcinoma
Official title: A Randomized, Placebo-Controlled, Double-Blind Phase 3 Study to Evaluate the Efficacy and Safety of Tislelizumab (BGB-A317) in Combination With Chemotherapy as First-Line Treatment in Patients With Unresectable, Locally Advanced Recurrent or Metastatic Esophageal Squamous Cell Carcinoma
Sponsor: BeiGene (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 649.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-12-11
Primary completion date: 2022-02-28
Completion date: 2024-08-22
Baseline population: Intent-to-treat (ITT) analysis set included all randomized participants
Plan to share individual participant data: YES
Clinical trial NCT05092581: COVID-19 Study of Pharmacokinetics, Safety, Tolerability, and Efficacy of Intravenous Anti-Spike(s) SARS-CoV-2 Monoclonal Antibodies (Casirivimab+Imdevimab) for the Treatment of Pediatric Patients Hospitalized Due to COVID-19
Official title: A Phase 1b, Open-Label, Single Dose Study Assessing the Pharmacokinetics, Safety, Tolerability, and Efficacy of Intravenous Anti-Spike(s) SARS-CoV-2 Monoclonal Antibodies (Casirivimab+Imdevimab) for the Treatment of Pediatric Patients Hospitalized Due to COVID-19
Sponsor: Regeneron Pharmaceuticals (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Emerging SARS-CoV-2 variants impacting susceptibility to study drug
Enrollment: 2.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-12-16
Primary completion date: 2022-06-09
Completion date: 2022-06-09
Plan to share individual participant data: YES
IPD sharing description: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
IPD time frame: When Regeneron has received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication, has made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry), has the legal authority to share the data, and has ensured the ability to protect participant privacy.
IPD access criteria: Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf