chufangao/CTO huggingface dataset:
Clinical trial NCT03338998: Efficacy, Safety and Tolerability of BAF312 Compared to Placebo in Patients With Intracerebral Hemorrhage (ICH).
Official title: A Phase II, Patient- and Investigator-blinded, Randomized, Placebo-controlled Study to Evaluate Efficacy, Safety and Tolerability of BAF312 (Siponimod) in Patients With Stroke Due to Intracerebral Hemorrhage (ICH)
Sponsor: Novartis (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 32.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-12-24
Primary completion date: 2020-05-13
Completion date: 2020-05-13
Plan to share individual participant data: YES
IPD sharing description: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
Clinical trial NCT03524898: NAPAGE: NAb-PAclitaxel and GEmcitabine in Advanced Soft Tissue Sarcoma
Official title: NAPAGE: NAb-PAclitaxel and GEmcitabine in Advanced Soft Tissue Sarcoma. A Multicenter Open-label Single Arm Phase Ib/IIa Trial
Sponsor: Swiss Group for Clinical Cancer Research (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: As Last patient last visit (LPLV) took place on 15/02/2022, the trial was ended prematurely on this date in accordance with SAKK/CI.
Enrollment: 39.0 (ACTUAL)
Number of arms: 1.0
Start date: 2018-10-02
Primary completion date: 2022-02-15
Completion date: 2022-02-15
Plan to share individual participant data: NO
Clinical trial NCT05544734: Hydrocodone Compared to Acetaminophen and Ibuprofen for Post-nail Procedure Analgesia
Official title: Analysis of Hydrocodone Compared to Acetaminophen and Ibuprofen for Post-nail Procedure Analgesia
Sponsor: Weill Medical College of Cornell University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 20.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-11-10
Primary completion date: 2023-05-15
Completion date: 2023-06-01
Plan to share individual participant data: NO
Clinical trial NCT04702568: A Long Term Safety Study of BCX9930 in Subjects With Paroxysmal Nocturnal Hemoglobinuria (PNH)
Official title: A Phase 2, Open-Label Study to Evaluate the Long-term Safety of Oral BCX9930 in Subjects With Paroxysmal Nocturnal Hemoglobinuria (PNH)
Sponsor: BioCryst Pharmaceuticals (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Sponsor decision
Enrollment: 19.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-12-18
Primary completion date: 2023-10-04
Completion date: 2023-10-04
Plan to share individual participant data: NO
Clinical trial NCT04359953: Efficacy of Hydroxychloroquine, Telmisartan and Azithromycin on the Survival of Hospitalized Elderly Patients With COVID-19
Official title: Efficacy of Hydroxychloroquine, Telmisartan and Azithromycin on the Survival of Hospitalized Elderly Patients With COVID-19: a Randomized, Multicenter, Adaptative Study
Acronym: COVID-Aging
Sponsor: University Hospital, Strasbourg, France (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: difficulty in recruiting
Enrollment: 16.0 (ACTUAL)
Number of arms: 4.0
Start date: 2020-04-25
Primary completion date: 2022-04-01
Completion date: 2022-06-01
Clinical trial NCT03060629: A Study to Assess the Efficacy of a Heterologous Prime/Boost Vaccine Regimen of Ad26.Mos4.HIV and Aluminum Phosphate-Adjuvanted Clade C gp140 in Preventing Human Immunodeficiency Virus (HIV) -1 Infection in Women in Sub-Saharan Africa
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 2b Efficacy Study of a Heterologous Prime/Boost Vaccine Regimen of Ad26.Mos4.HIV and Aluminum Phosphate-adjuvanted Clade C gp140 in Preventing HIV-1 Infection in Adult Women in Sub-Saharan Africa
Sponsor: Janssen Vaccines & Prevention B.V. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Study was terminated by the sponsor after the last participant completed the Month 24 visit as the pre-specified criteria to continue the study were not met.
Enrollment: 2636.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-11-03
Primary completion date: 2022-02-02
Completion date: 2022-02-02
Clinical trial NCT04422431: Copper Concentration & Histopathologic Changes in Liver Biopsy in Participants With Wilson Disease Treated With ALXN1840
Official title: A Phase 2, Single-arm Pathologist-blinded 48-week Study Using Liver Biopsy Specimens to Assess Copper Concentration and Histopathologic Changes in ALXN1840-treated Patients With Wilson Disease Followed by an up to 48-weeks Extension Period
Sponsor: Alexion Pharmaceuticals, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 31.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-12-02
Primary completion date: 2022-05-21
Completion date: 2023-05-17
Baseline population: The Full Analysis Set in the Treatment Period included all participants who received at least 1 dose of study drug in the Treatment Period and had at least a Baseline liver copper (Cu) value evaluable.
Plan to share individual participant data: NO
Clinical trial NCT03999216: Comparing Diuretic Strategies in Hospitalized Heart Failure
Official title: Creating a Platform for Point-of-Care Pragmatic Clinical Trials: Comparing Diuretic Strategies in Heart Failure
Sponsor: Stanford University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: WITHDRAWN 
Why stopped: Due to administrative and logistical barriers this trial has been withdrawn.
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2023-07-31
Primary completion date: 2024-01-31
Completion date: 2024-06-30
Plan to share individual participant data: NO
Clinical trial NCT03952130: A Study of LY900014 Compared to Insulin Lispro (Humalog) in Adults With Type 1 Diabetes
Official title: A Prospective, Randomized, Double-Blind Comparison of LY900014 to Insulin Lispro in Combination With Insulin Glargine or Insulin Degludec in Adults With Type 1 Diabetes
Sponsor: Eli Lilly and Company (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 354.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-05-29
Primary completion date: 2022-01-10
Completion date: 2022-01-10
Baseline population: All randomized participants.
Plan to share individual participant data: YES
IPD sharing description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
IPD time frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
IPD access criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Clinical trial NCT04444141: A Study of PD-1/CTLA-4 Bispecific AK104 in Relapsed or Refractory Peripheral T-cell Lymphoma
Official title: A Multicenter, Open-label, Phase Ib/II Study of AK104, a PD-1/CTLA-4 Bispecific Antibody, in Subjects With Relapsed or Refractory Peripheral T Cell Lymphoma
Sponsor: Akeso (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Due to difficuty of erollment and consideration of clinical guideline,The sponsor decided to stop study.
Enrollment: 6.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-05-15
Primary completion date: 2022-09-30
Completion date: 2022-09-30
Clinical trial NCT03912831: Study to Evaluate the Safety and Efficacy of KITE-439 in HLA-A*02:01+ Adults With Relapsed/Refractory HPV16+ Cancers
Official title: A Phase 1 Study Evaluating the Safety and Efficacy of HPV16 E7 T Cell Receptor Engineered T Cells (KITE-439) in HLA-A*02:01+ Subjects With Relapsed/Refractory HPV16+ Cancers
Sponsor: Gilead Sciences (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Development program terminated
Enrollment: 8.0 (ACTUAL)
Number of arms: 7.0
Start date: 2019-04-30
Primary completion date: 2022-02-18
Completion date: 2022-02-18
Baseline population: Safety analysis set included all participants who were treated with any dose of KITE-439.
Plan to share individual participant data: NO
Clinical trial NCT04771351: Study to Evaluate a Single Dose of STI-2020 (COVI-AMG™) in Hospitalized Adults With COVID-19
Official title: A Randomized, Blinded-controlled Study to Evaluate the Safety and Efficacy of a Single Dose of STI-2020 (COVI-AMG™) in Hospitalized Adult Patients With COVID-19
Sponsor: Sorrento Therapeutics, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: A different study will be conducted.
Enrollment: 0.0 (ACTUAL)
Number of arms: 3.0
Start date: 2021-04-30
Primary completion date: 2021-08-31
Completion date: 2021-10-31
Clinical trial NCT02710396: Genetic Predictors of Benefit to Pembrolizumab
Official title: Identifying Genetic Predictors of Durable Clinical Benefit to Pembrolizumab in Advanced Non-small Cell Lung Cancer (NSCLC) Alone and in Combination With Chemotherapy.
Sponsor: Columbia University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Frontline pembrolizumab approved in NSCLC as monotherapy and in combination with chemotherapy representing a new standard of care.
Enrollment: 19.0 (ACTUAL)
Number of arms: 3.0
Start date: 2016-05-31
Primary completion date: 2021-03-10
Completion date: 2021-03-10
Baseline population: No subjects enrolled to cohort 3
Plan to share individual participant data: NO
Clinical trial NCT03893617: Brief Stresses Experimental Study
Official title: Brief Stresses and DNA Integrity: An Experimental Analysis
Sponsor: University of Pittsburgh (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Due to challenges associated with the Covid-19 pandemic, we were unable to complete recruitment as planned during the period we had funding to do so.
Enrollment: 239.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-10-05
Primary completion date: 2022-01-27
Completion date: 2022-01-27
Clinical trial NCT03572062: A Study to Evaluate the Safety and Immunogenicity of an Adjuvanted RSV Vaccine in Healthy Older Adults
Official title: A PHASE 1/2, PLACEBO-CONTROLLED, RANDOMIZED, OBSERVER-BLIND,DOSE-FINDING, FIRST-IN-HUMAN STUDY TO DESCRIBE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF AN ADJUVANTED RESPIRATORY SYNCYTIAL VIRUS (RSV) VACCINE IN HEALTHY OLDER ADULTS
Sponsor: Pfizer (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Study halted prematurely by sponsor and will not resume, participants are no longer being examined or receiving intervention.
Enrollment: 317.0 (ACTUAL)
Number of arms: 10.0
Start date: 2018-06-05
Primary completion date: 2020-06-23
Completion date: 2020-08-19
Baseline population: Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
Limitations and caveats: Study follow up of the Month-0, Month-2 cohort was terminated early due to sponsor decision, with all participants followed up through 6 months after Vaccination 2.
Plan to share individual participant data: YES
IPD sharing description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
Clinical trial NCT05541952: BCG Re-vaccination for Primary Tuberculosis Prophylaxis in the Prison Population
Official title: BCG Re-vaccination for Primary Tuberculosis Prophylaxis in the Prison Population
Acronym: PPT-BCG
Sponsor: Federal University of Mato Grosso (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: WITHDRAWN 
Why stopped: New evidence points to a new candidate vaccine, with a superior trial to BCG.
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-08-17
Primary completion date: 2020-08-17
Completion date: 2020-08-17
Clinical trial NCT02975336: A Phase II Study of M2951 in SLE
Official title: A Phase II, Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study To Evaluate the Safety and Efficacy of M2951 in Subjects With SLE
Sponsor: EMD Serono (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Study is completed; primary analysis completed.
Enrollment: 469.0 (ACTUAL)
Number of arms: 8.0
Start date: 2017-01-04
Primary completion date: 2019-11-27
Completion date: 2020-03-23
Limitations and caveats: Primary and Secondary endpoints were planned to be analyze only for Double-Blind Placebo-controlled period.
Clinical trial NCT04357951: D-cycloserine Augmented Treatment for Youth With Tic Disorders
Official title: D-cycloserine Augmented Treatment: Enhancing Extinction Learning in Youth With Tic Disorders
Sponsor: Johns Hopkins University (OTHER)
Study type: INTERVENTIONAL
Phase: EARLY_PHASE1
Status: WITHDRAWN 
Why stopped: Low enrollment
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2023-04-15
Primary completion date: 2024-03-31
Completion date: 2024-09-30
Plan to share individual participant data: NO
IPD sharing description: This is a pilot study intended to demonstrate feasibility and test preliminary efficacy. The investigators do not plan to share individual participant data.
Clinical trial NCT04353271: Trial of Hydroxychloroquine In Covid-19 Kinetics
Official title: A Randomized Phase 2/3 Trial of Hydroxychloroquine In Covid-19 Kinetics
Acronym: THICK
Sponsor: University of South Alabama (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: TERMINATED 
Why stopped: FDA recommendations to not use outside of the hospital setting or in a clinical trial due to the risk of cardiac arrhythmias
Enrollment: 3.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-04-17
Primary completion date: 2020-07-08
Completion date: 2020-07-08
Plan to share individual participant data: NO
Clinical trial NCT04073615: A Study of Rivoceranib and Trifluridine/Tipiracil for Metastatic Colorectal Cancer (mCRC)
Official title: Phase 1b/2 Open-label Study to Evaluate the Safety, Tolerability and Efficacy of Rivoceranib or Trifluridine/Tipiracil as Monotherapies and Rivoceranib and Trifluridine/Tipiracil as Combination Therapy in Subjects With Metastatic Colorectal Cancer
Sponsor: Elevar Therapeutics (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Phase 2 portion of the study was not performed due to redirection of the rivoceranib development plan by the Sponsor.
Enrollment: 29.0 (ACTUAL)
Number of arms: 3.0
Start date: 2019-11-18
Primary completion date: 2023-05-31
Completion date: 2023-05-31
Clinical trial NCT03008616: Study of the Efficacy and Safety of AMAG-423 (Digoxin Immune Fab) in Antepartum Subjects With Severe Preeclampsia
Official title: A Phase 2b/3a, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of the Efficacy and Safety of AMAG-423, a Digoxin Immune Fab, in Antepartum Subjects With Severe Preeclampsia
Sponsor: AMAG Pharmaceuticals, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: TERMINATED 
Why stopped: Following a recommendation from the Data and Safety Monitoring Board (DSMB), the study was stopped early for futility. There were no safety concerns raised.
Enrollment: 59.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-04-12
Primary completion date: 2020-08-13
Completion date: 2020-08-13
Plan to share individual participant data: NO
Clinical trial NCT04659161: A Study to Assess Efficacy and Safety of KarXT in Acutely Psychotic Hospitalized Adult Patients With Schizophrenia (EMERGENT-2)
Official title: A Phase 3, Randomized, Double-blind, Parallel-group, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of KarXT in Acutely Psychotic Hospitalized Adults With DSM-5 Schizophrenia
Sponsor: Karuna Therapeutics (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 252.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-12-16
Primary completion date: 2022-05-24
Completion date: 2022-05-24
Baseline population: The Intent-to-Treat (ITT) population included all participants who were randomized to the study. Participants were analyzed according to randomized treatment.
Plan to share individual participant data: NO
Clinical trial NCT02859415: Continuous 24h Intravenous Infusion of Mithramycin, an Inhibitor of Cancer Stem Cell Signaling, in People With Primary Thoracic Malignancies or Carcinomas, Sarcomas or Germ Cell Neoplasms With Pleuropulmonary Metastases
Official title: Phase I/II Evaluation of Continuous 24h Intravenous Infusion of Mithramycin, an Inhibitor of Cancer Stem Cell Signaling, in Patients With Primary Thoracic Malignancies or Carcinomas, Sarcomas or Germ Cell Neoplasms With Pleuropulmonary Metastases
Sponsor: National Institutes of Health Clinical Center (CC) (NIH)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Slow/Insufficient accrual
Enrollment: 3.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-08-08
Primary completion date: 2019-12-06
Completion date: 2021-12-01
Plan to share individual participant data: YES
Clinical trial NCT02558023: The Treatment of Hypertension Associated With Severe Preeclampsia (PE). A Trial of Urapidil Versus Nicardipine
Official title: The Treatment of Hypertension Associated With Severe Preeclampsia. A Randomize Controlled Trial of Urapidil Versus Nicardipine. The Uranic Trial
Acronym: Uranic
Sponsor: University Hospital, Strasbourg, France (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: no candidats
Enrollment: 14.0 (ACTUAL)
Number of arms: 2.0
Start date: 2015-09-30
Primary completion date: 2020-08-31
Completion date: 2020-08-31
Clinical trial NCT05212116: A Study of SDI-118 in Participants in Remission From Depression
Official title: A Phase Ib, Exploratory, Double Blind, Placebo Controlled, Parallel Group, Study of SDI-118 to Evaluate Safety, Tolerability, and Pharmacodynamics Including Cognitive Function in Male and Female Participants in Remission From Depression
Sponsor: Syndesi Therapeutics (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: Development Plan Amended
Enrollment: 0.0 (ACTUAL)
Number of arms: 3.0
Start date: 2021-09-16
Primary completion date: 2022-03-11
Completion date: 2022-03-11
Plan to share individual participant data: NO
Clinical trial NCT03630952: Efficacy and Safety Trial of Conbercept Intravitreal Injection for Neovascular AMD (PANDA-2)
Official title: A Multicenter, Double-Masked, Randomized, Dose-Ranging Trial to Evaluate the Efficacy and Safety of Conbercept Intravitreal Injection in Subjects With Neovascular Age-Related Macular Degeneration (AMD) (PANDA-2)
Sponsor: Chengdu Kanghong Biotech Co., Ltd. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: desired primary endpoint was not met
Enrollment: 1157.0 (ACTUAL)
Number of arms: 3.0
Start date: 2018-12-21
Primary completion date: 2020-09-10
Completion date: 2021-05-19
Plan to share individual participant data: NO
Clinical trial NCT01897454: Gemcitabine Hydrochloride, and Radiation Therapy in Patients With Borderline Resectable Pancreatic Cancer
Official title: A Phase II Trial of Preoperative FOLFIRINOX Followed by Gemcitabine Based Chemoradiotherapy in Patients With Borderline Resectable Pancreatic Adenocarcinoma
Sponsor: Albert Einstein College of Medicine (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Study was terminated due to slower than anticipated accrual
Enrollment: 23.0 (ACTUAL)
Number of arms: 1.0
Start date: 2012-01-27
Primary completion date: 2021-11-01
Completion date: 2021-11-01
Clinical trial NCT04353310: Evaluating Effects of Curcumin in Moderate to Severe Asthmatics
Official title: Evaluating the Effects of Curcumin in Moderate to Severe Asthmatics
Sponsor: Loma Linda University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: No funding
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-09-30
Primary completion date: 2021-11-09
Completion date: 2021-11-09
Plan to share individual participant data: NO
Clinical trial NCT02960893: Trial in Adult Subjects With Spinocerebellar Ataxia
Official title: A Phase IIb/III, Randomized, Double-blind, Placebo-controlled Trial of Troriluzole in Adult Subjects With Spinocerebellar Ataxia
Sponsor: Biohaven Pharmaceuticals, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: COMPLETED 
Enrollment: 141.0 (ACTUAL)
Number of arms: 2.0
Start date: 2016-12-15
Primary completion date: 2017-08-18
Completion date: 2024-09-20
Baseline population: Safety Analysis Set (Randomization Phase): All participants who received at least one dose of study drug during the Randomization Phase.
Plan to share individual participant data: NO
Clinical trial NCT03926169: A Global Study Comparing Risankizumab to Placebo in Adult Participants With Moderate to Severe Hidradenitis Suppurativa
Official title: A Phase 2, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Safety and Efficacy of Risankizumab in Adult Subjects With Moderate to Severe Hidradenitis Suppurativa
Acronym: DETERMINED 1
Sponsor: AbbVie (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 243.0 (ACTUAL)
Number of arms: 6.0
Start date: 2019-06-03
Primary completion date: 2021-02-02
Completion date: 2021-08-02
Plan to share individual participant data: YES
IPD sharing description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
IPD time frame: For details on when studies are available for sharing, please refer to the link below.
IPD access criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Use Agreement (DUA). For more information on the process, or to submit a request, visit the following link.
Clinical trial NCT04802837: Safety, Tolerability and the Pharmacokinetics of Ridinilazole in Adolescent Subjects
Official title: A Randomized, Double Blind, Active Controlled Study to Evaluate the Safety and Tolerability of Ridinilazole Compared With Vancomycin and to Assess the Pharmacokinetics of Ridinilazole in Adolescent Subjects (Aged 12 to <18 Years) With Clostridioides Difficile Infection
Acronym: Ri-CoDIFy 3
Sponsor: Summit Therapeutics (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: SMT19969-C006 study was terminated in alignment with corporate decision to pursue further development of drug candidate with a partner.
Enrollment: 2.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-05-19
Primary completion date: 2021-09-17
Completion date: 2022-09-28
Plan to share individual participant data: NO