chufangao/CTO huggingface dataset:
Clinical trial NCT01028716: Donor Peripheral Blood Stem Cell Transplant in Treating Patients With Hematologic Malignancies
Official title: Nonmyeloablative Hematopoietic Cell Transplantation (HCT) for Patients With Hematologic Malignancies Using Related, HLA-Haploidentical Donors: A Phase II Trial of Peripheral Blood Stem Cells (PBSC) as the Donor Source
Sponsor: Fred Hutchinson Cancer Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: The study experienced lower accrual rates after the onset of COVID. Upon review of the collected data it was deemed that an adequate amount of subjects has been enrolled to date to assess study aims.
Enrollment: 46.0 (ACTUAL)
Number of arms: 1.0
Start date: 2010-05-19
Primary completion date: 2021-10-07
Completion date: 2021-10-07
Plan to share individual participant data: NO
Clinical trial NCT04267679: Cannabidiol for Anxiety
Official title: Prospective Evaluation of Cannabidiol (CBD) on Anxiety: A Pilot Study
Sponsor: CB2 Insights (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Stopped due to COVID-19 pandemic.
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-03-01
Primary completion date: 2020-12-01
Completion date: 2020-12-01
Clinical trial NCT05472506: Oral AHR Antagonist in Combination With Nivolumab in Patients With PD-1 Resistant Metastatic or Recurrent Head and Neck Cancer
Official title: A Phase 1b, Open-Label, Single-Arm Dose-Expansion Study of IK-175, an Oral Aryl Hydrocarbon Receptor Inhibitor, in Combination With Nivolumab in Patients With Primary PD-1 Inhibitor Resistant Metastatic or Locally Incurable, Recurrent HNSCC
Sponsor: Ikena Oncology (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: Sponsor Decision
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2023-03-31
Primary completion date: 2023-04-30
Completion date: 2023-04-30
Plan to share individual participant data: NO
Clinical trial NCT04194203: A Study of Bevacizumab, Carboplatin, and Paclitaxel or Pemetrexed With or Without Atezolizumab in Chemotherapy-Naïve Patients With Stage IV Non-Squamous Non-Small Cell Lung Cancer (IMpower151)
Official title: A Phase III, Randomized, Double-Blind Study of Bevacizumab, Carboplatin, and Paclitaxel or Pemetrexed With or Without Atezolizumab in Chemotherapy-Naïve Patients With Stage IV Non-Squamous Non-Small Cell Lung Cancer (IMpower151)
Sponsor: Hoffmann-La Roche (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 305.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-04-09
Primary completion date: 2023-02-02
Completion date: 2024-06-27
Plan to share individual participant data: YES
IPD sharing description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.clinicalstudydatarequest.com). Further details on Roche's criteria for eligible studies are available here (https://clinicalstudydatarequest.com/Study-Sponsors/Study-Sponsors-Roche.aspx). For further details on Roche's Global Policy on Sharing of Clinical Study Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).
Clinical trial NCT05060276: Study to Assess an Anti-Trop2 Antibody Drug Conjugate in Relapsed or Refractory Solid Tumors
Official title: A Phase 1B, Dose-Escalation Study of the Safety and Preliminary Efficacy of an Anti-Trop2 Antibody Drug Conjugate (STI-3258) in Patients With Relapsed or Refractory Solid Tumors
Sponsor: Sorrento Therapeutics, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: Protocol changed to Phase 2
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2022-12-31
Primary completion date: 2024-05-31
Completion date: 2024-12-31
Clinical trial NCT04025567: Vancomycin in Patients With Unresectable Fibrolamellar Hepatocellular Carcinoma (FLC) Oral
Official title: Phase II Study of Oral Vancomycin in Patients With Unresectable Fibrolamellar Hepatocellular Carcinoma (FLC)
Sponsor: National Institutes of Health Clinical Center (CC) (NIH)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: slow/insufficient accrual.
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-03-12
Primary completion date: 2021-12-31
Completion date: 2021-12-31
Clinical trial NCT04074590: Study of Efficacy, Safety, and Tolerability of LYS006, in Patients With Mild to Moderate Ulcerative Colitis
Official title: A Randomized, Multi-center, Subject and Investigator-blinded, Placebo-controlled, Parallel-group Study to Assess the Efficacy Safety and Tolerability of LYS006 in Patients With Mild to Moderate Ulcerative Colitis
Sponsor: Novartis (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Sponsor decision due to strategic considerations
Enrollment: 23.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-02-03
Primary completion date: 2022-11-07
Completion date: 2022-11-07
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 NCT03648372: A Study of TAK-981 in People With Advanced Solid Tumors or Cancers in the Immune System
Official title: An Open Label, Dose-Escalation, Phase 1/2 Study to Evaluate the Safety, Tolerability, Preliminary Efficacy and Pharmacokinetics of TAK-981 in Adult Patients With Advanced or Metastatic Solid Tumors or Relapsed/Refractory Hematologic Malignancies
Sponsor: Takeda (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Enrolment Challenges
Enrollment: 109.0 (ACTUAL)
Number of arms: 7.0
Start date: 2018-10-01
Primary completion date: 2023-11-22
Completion date: 2023-12-18
Plan to share individual participant data: YES
IPD sharing description: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
IPD access criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
Clinical trial NCT04601077: The Evaluation of Nitric Oxide Generating Lozenges on Outcome in Newly Diagnosed COVID-19 Patient of African American and Hispanic Origin
Official title: Pilot Study: The Evaluation of Nitric Oxide Generating Lozenges on Outcome in Newly Diagnosed COVID-19 Patient of African American and Hispanic Origin
Sponsor: Nitric Oxide Innovations LLC (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: The study stopped due to futility.
Enrollment: 524.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-11-01
Primary completion date: 2022-11-30
Completion date: 2022-11-30
Plan to share individual participant data: NO
Clinical trial NCT03300570: Dolcanatide in Preventing Colorectal Cancer in Healthy Volunteers
Official title: Phase I Double-Blind, Placebo-Controlled Trial of 27 mg Dolcanatide (SP-333) to Demonstrate Colorectal Bioactivity in Healthy Volunteers
Sponsor: National Cancer Institute (NCI) (NIH)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 27.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-07-27
Primary completion date: 2019-01-02
Completion date: 2021-05-17
Clinical trial NCT03397134: Study to Evaluate Efficacy and Safety of Roluperidone (MIN-101) in Adult Patients With Negative Symptoms of Schizophrenia
Official title: A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Monotherapy, 12-Week Study to Evaluate the Efficacy and Safety of 2 Fixed Doses of MIN-101 in Adult Patients With Negative Symptoms of Schizophrenia, Followed by a 40-Week Open-Label Extension
Sponsor: Minerva Neurosciences (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 515.0 (ACTUAL)
Number of arms: 4.0
Start date: 2017-12-15
Primary completion date: 2020-05-26
Completion date: 2021-02-15
Baseline population: Patients who Started Treatment.
Clinical trial NCT02536300: Dose Optimization Study of Idelalisib in Follicular Lymphoma
Official title: Dose Optimization Study of Idelalisib in Follicular Lymphoma
Sponsor: Gilead Sciences (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Gilead has made the decision to close the study due to enrollment challenges
Enrollment: 96.0 (ACTUAL)
Number of arms: 3.0
Start date: 2016-01-14
Primary completion date: 2022-09-27
Completion date: 2022-09-27
Baseline population: Safety analysis set included all participants who received at least 1 dose of study drug.
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 NCT03110445: Cancer/Testis Antigen Immunotherapy Phase I Study With 740-CTA Vaccinia Virus
Official title: Monocentric Open Label Phase I Immunotherapy Trial of Breast Cancer Patients With a Non-replicating Recombinant Vaccinia Virus Expressing Cancer/Testis Antigens and Cluster of Differentiation Antigen 80 (CD80)-CD40L Costimulatory Molecules.
Acronym: rVV-740CTA
Sponsor: University Hospital, Basel, Switzerland (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: not sufficiently staff available to perform trial
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-03-31
Primary completion date: 2021-09-30
Completion date: 2021-09-30
Plan to share individual participant data: NO
IPD sharing description: publication per reviewed journal
Clinical trial NCT05203367: Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BAR 502 in Healthy Subjects
Official title: Randomized, Double-Blind, Placebo-Controlled, Phase 1 Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single-Ascending Doses of BAR 502 in Healthy Subjects
Sponsor: BAR Pharmaceuticals s.r.l. (NETWORK)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: Update development program
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-11-25
Primary completion date: 2023-03-30
Completion date: 2023-03-30
Plan to share individual participant data: NO
Clinical trial NCT03745352: Pevonedistat With Azacitidine Versus Azacitidine Alone in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia
Official title: A Randomized Phase II Trial of MLN4924 (Pevonedistat) With Azacitidine Versus Azacitidine in Adult Relapsed or Refractory Acute Myeloid Leukemia
Sponsor: National Cancer Institute (NCI) (NIH)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Inadequate accrual rate
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-05-20
Primary completion date: 2021-08-19
Completion date: 2021-08-19
Plan to share individual participant data: YES
IPD sharing description: NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page
Clinical trial NCT06254118: Treatment of Periodontitis in Menopausal Patients
Official title: Non-Surgical Treatment of Periodontitis in Menopausal Patients
Sponsor: King Abdulaziz University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 20.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-01-22
Primary completion date: 2022-01-22
Completion date: 2023-01-30
Plan to share individual participant data: NO
IPD sharing description: no IPD to be shared
Clinical trial NCT03787082: Chlorhexidine Mouthwash and Oral Nitrate in Adults With Pulmonary Hypertension
Official title: A Randomized Trial of Chlorhexidine Mouthwash and Oral Nitrate in Adults With Pulmonary Hypertension
Sponsor: University of Pittsburgh (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: Study was never able to start after the pandemic restrictions lifted
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-12-31
Primary completion date: 2023-12-31
Completion date: 2023-12-31
Plan to share individual participant data: YES
IPD sharing description: After de-identification, all participant data collected during the trial will be made available.
IPD time frame: Data will be made following publication.
IPD access criteria: Data will be available publicly.
Clinical trial NCT04676867: Effect of Dalcetrapib in Patients With Confirmed Mild to Moderate COVID-19
Official title: A Double-blind, Placebo-controlled, Phase 2a Proof-of-concept Trial of Dalcetrapib in Patients With Confirmed Mild to Moderate COVID-19
Sponsor: DalCor Pharmaceuticals (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 227.0 (ACTUAL)
Number of arms: 4.0
Start date: 2021-01-11
Primary completion date: 2021-05-17
Completion date: 2021-05-17
Baseline population: Of the 225 randomized subjects, a total of 208 subjects received at least one dose of study medication, for which baseline data are presented here. The overall number of baseline participants in each arm reflects the number of subjects who took at least one dose of study medication in each arm, not the total number randomized in each arm.
Limitations and caveats: Small sample size, remote study, and patients were self-sampling for the polymerase chain reaction (PCR) testing albeit under supervision.
Plan to share individual participant data: NO
Clinical trial NCT04098406: Therapeutic Nanocatalysis to Slow Disease Progression of Amyotrophic Lateral Sclerosis (ALS)
Official title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study in Early Symptomatic Amyotrophic Lateral Sclerosis Patients on Stable Background Therapy to Assess Bioenergetic Catalysis With CNM-Au8 to Slow Disease Progression in ALS.
Acronym: RESCUE-ALS
Sponsor: Clene Nanomedicine (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 45.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-12-19
Primary completion date: 2021-07-13
Completion date: 2021-07-13
Plan to share individual participant data: NO
Clinical trial NCT06044805: Therapeutic Efficacy of Chloroquine Plus Primaquine in the Treatment of Uncomplicated Plasmodium Vivax
Official title: Monitoring Therapeutic Efficacy of Chloroquine Plus Primaquine in the Treatment of Uncomplicated Plasmodium Vivax Based on Clinical, Parasitologic and Hematologic Parameters in Shecha Health Center: Open Label Clinical Trial
Acronym: CQ+PQ
Sponsor: Wollega University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 100.0 (ACTUAL)
Number of arms: 1.0
Start date: 2022-12-19
Primary completion date: 2023-03-13
Completion date: 2023-03-15
Plan to share individual participant data: NO
Clinical trial NCT03020992: A Study to Assess the Effects of Certolizumab Pegol on the Reduction of Anterior Uveitis (AU) Flares in Axial Spondyloarthritis Subjects With a Documented History of AU
Official title: Multicenter, Open-Label Study to Assess the Effects of Certolizumab Pegol on the Reduction of Anterior Uveitis Flares in Axial Spondyloarthritis Subjects With a History of Anterior Uveitis (C-VIEW)
Acronym: C-VIEW
Sponsor: UCB Pharma (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 89.0 (ACTUAL)
Number of arms: 1.0
Start date: 2016-12-21
Primary completion date: 2019-12-04
Completion date: 2020-01-23
Baseline population: The Safety Set (SS) consisted of all study participants in the Enrolled Set (ES) who had received at least 1 dose of IMP.
Clinical trial NCT04046887: Study of Lonsurf in Combination With Gemcitabine and Nab-Paclitaxel in Patients With Advanced (PDAC)
Official title: Phase I Study of Lonsurf in Combination With Gemcitabine and Nab-Paclitaxel in Patients With Advanced Pancreatic Ductal Adenocarcinoma (PDAC)
Sponsor: Indiana University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Unable to proceed due to Neulasta difficulties and other complications.
Enrollment: 14.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-09-11
Primary completion date: 2021-05-10
Completion date: 2023-10-04
Clinical trial NCT02288247: A Study to Assess the Benefit of Treatment Beyond Progression With Enzalutamide in Men Who Are Starting Treatment With Docetaxel After Worsening of Their Prostate Cancer When Taking Enzalutamide Alone
Official title: A Randomized, Double Blind, Placebo-Controlled, Phase IIIb Study of the Efficacy and Safety of Continuing Enzalutamide in Chemotherapy Naïve Metastatic Castration Resistant Prostate Cancer Patients Treated With Docetaxel Plus Prednisolone Who Have Progressed on Enzalutamide Alone
Acronym: PRESIDE
Sponsor: Astellas Pharma Inc (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 688.0 (ACTUAL)
Number of arms: 2.0
Start date: 2014-12-01
Primary completion date: 2020-04-30
Completion date: 2024-03-13
Baseline population: Safety Analysis Set 1 included all participants who received at least one dose of investigational medicinal product (IMP) in period 1.
Plan to share individual participant data: YES
IPD sharing description: Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as compounds terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com.
IPD time frame: Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.
IPD access criteria: Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.
Clinical trial NCT04985968: The Efficacy and Safety of Cobitolimod in Participants With Moderate to Severe Active Left-Sided Ulcerative Colitis
Official title: A Randomised Double-Blind Placebo-Controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of Cobitolimod as an Induction and Maintenance Therapy in Participants With Moderate to Severe Active Left-Sided Ulcerative Colitis
Acronym: CONCLUDE
Sponsor: InDex Pharmaceuticals (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Due to futility
Enrollment: 171.0 (ACTUAL)
Number of arms: 3.0
Start date: 2021-11-24
Primary completion date: 2023-12-20
Completion date: 2023-12-20
Plan to share individual participant data: NO
Clinical trial NCT02874651: ADjuVant Apatinib in Nasopharyngeal Carcinoma Patients With Residual Epstein-Barr Virus (EBV) DNA Following Radiotherapy
Official title: ADjuVant Apatinib in Nasopharyngeal Carcinoma Patients With Residual Epstein-Barr Virus (EBV) DNA Following Radiotherapy With or Without Chemotherapy
Acronym: ADVANCE
Sponsor: Sun Yat-sen University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Unacceptable toxicity (nasopharynx necrosis and massive hemorrhage)
Enrollment: 25.0 (ACTUAL)
Number of arms: 2.0
Start date: 2016-10-31
Primary completion date: 2018-11-29
Completion date: 2020-08-27
Plan to share individual participant data: NO
Clinical trial NCT03829618: Lidocaine Administration During Flexible Bronchoscopy and Endobronchial Ultrasound
Official title: Lidocaine Administration During Flexible Bronchoscopy and Endobronchial Ultrasound
Sponsor: Milton S. Hershey Medical Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: COVID lack of cases/recruitment
Enrollment: 29.0 (ACTUAL)
Number of arms: 3.0
Start date: 2019-04-01
Primary completion date: 2020-08-31
Completion date: 2020-08-31
Limitations and caveats: The target enrollment was not reached secondary to the COVID-19 pandemic.
Plan to share individual participant data: NO
Clinical trial NCT05953688: POC Study to Evaluate the Efficacy and Safety of ESK-001 in Patients With Active Intermediate, Posterior, or Pan NIU
Official title: A Proof-of-Concept, Randomized, Double-Masked Study to Evaluate the Efficacy and Safety of ESK-001 in Patients With Active Noninfectious Intermediate, Posterior, or Panuveitis (OPTYK-1)
Acronym: OPTYK-1
Sponsor: Alumis Inc (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Terminated based on interim efficacy data that did not meet the Sponsor's criteria.
Enrollment: 36.0 (ACTUAL)
Number of arms: 2.0
Start date: 2023-06-14
Primary completion date: 2024-08-13
Completion date: 2024-08-13
Plan to share individual participant data: NO
Clinical trial NCT04070326: A Study of Lanadelumab to Prevent Hereditary Angioedema (HAE) Attacks in Children
Official title: SPRING STUDY: An Open-Label, Multicenter, Phase 3 Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Lanadelumab for Prevention Against Acute Attacks of Hereditary Angioedema (HAE) in Pediatric Subjects 2 to <12 Years of Age
Acronym: SPRING
Sponsor: Takeda (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 21.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-08-19
Primary completion date: 2021-10-30
Completion date: 2021-10-30
Baseline population: The Safety Analysis Set consisted of all participants who received any study drug.
Plan to share individual participant data: YES
IPD sharing description: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
IPD access criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.