chufangao/CTO huggingface dataset:
Clinical trial NCT05622058: A Study of ALRN-6924 for Protection of Chemotherapy-Induced Side Effects in Patients With TP53-Mutant Breast Cancer
Official title: A Phase 1b Clinical Study of the Dual MDMX/MDM2 Inhibitor, ALRN-6924, as a Chemoprotection Agent in Patients With TP53-Mutated, HER2 Negative Breast Cancer Receiving Neoadjuvant or Adjuvant Chemotherapy With Docetaxel, Doxorubicin, and Cyclophosphamide (TAC)
Sponsor: Aileron Therapeutics, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: The study has been terminated early given that the first four patients enrolled have experienced Grade 4 neutropenia and alopecia after cycle 1 and as such failed to meet the primary endpoint and the main secondary endpoint.
Enrollment: 6.0 (ACTUAL)
Number of arms: 1.0
Start date: 2023-01-09
Primary completion date: 2023-02-22
Completion date: 2023-02-22
Clinical trial NCT05504486: Open-label Brexpiprazole fMRI Trial in Adults With Major Depressive Disorder and Anxiety
Official title: A Phase 4, Multicenter, Single-arm, Open-label, Interventional fMRI Trial to Assess the Effect of Brexpiprazole as Adjunctive Therapy on Functional Brain Network Organization in Adults With Major Depressive Disorder and Symptoms of Anxiety
Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: WITHDRAWN 
Why stopped: Sponsor strategic decision
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2022-08-29
Primary completion date: 2023-03-22
Completion date: 2023-04-05
Plan to share individual participant data: NO
Clinical trial NCT04038437: A Trial of CPX-351 Lower Intensity Therapy (LIT) Plus Venetoclax as First Line Treatment for Subjects With AML
Official title: A Phase 1b Trial of CPX-351 Lower Intensity Therapy (LIT) Plus Venetoclax as First Line Treatment for Subjects With AML Who Are Unfit for Intensive Chemotherapy
Sponsor: Jazz Pharmaceuticals (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 35.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-10-15
Primary completion date: 2022-04-26
Completion date: 2022-09-24
Clinical trial NCT03597282: A Personal Cancer Vaccine (NEO-PV-01) and APX005M or Ipilimumab With Nivolumab in Patients With Advanced Melanoma
Official title: An Open-label, Phase 1B Study of NEO-PV-01 + CD40 Agonist Antibody (APX005M) or Ipilimumab With Nivolumab in Patients With Advanced or Metastatic Melanoma
Sponsor: BioNTech SE (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Closed due to historically slow enrollment compounded by the COVID-19 pandemic.
Enrollment: 22.0 (ACTUAL)
Number of arms: 7.0
Start date: 2018-10-08
Primary completion date: 2020-05-05
Completion date: 2020-08-11
Plan to share individual participant data: NO
Clinical trial NCT04079413: Efficacy and Safety of GP40071 Compared to NovoRapid® Penfill® in Type 1 Diabetes Mellitus Patients
Official title: An Open-label, Randomized, Multi-center, Parallel-group Clinical Trial Comparing the Efficacy and Safety of GP40071 (OOO GEROPHARM, Russia) Compared to NovoRapid® Penfill® (Novo Nordisk A/S, Denmark) in Type 1 Diabetes Mellitus Patients
Sponsor: Geropharm (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 264.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-06-03
Primary completion date: 2020-01-21
Completion date: 2020-01-21
Plan to share individual participant data: UNDECIDED
Clinical trial NCT05564416: Testing Anti-Cancer Drugs Erdafitinib With or Without Atezolizumab in Patients With Localized Bladder Cancer Not Able to Receive Cisplatin Chemotherapy, NERA Trial
Official title: An Open Label, Randomized Phase II Study Neoadjuvant Erdafitinib With or Without Atezolizumab in Cisplatin-Ineligible Patients With Muscle Invasive Bladder Cancer (NERA)
Sponsor: National Cancer Institute (NCI) (NIH)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Feasibility issues per Complete Sheet
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2023-10-12
Primary completion date: 2023-11-03
Completion date: 2023-11-03
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 NCT05735756: Effect of Citalopram on Chest Pain in Patients With Functional Chest Pain
Official title: Effect of Citalopram on Chest Pain in Patients With Functional Chest Pain
Acronym: Ci-FCP
Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: The clinical trial has ended prematurely due to low patient recruitment
Enrollment: 1.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-01-17
Primary completion date: 2022-04-22
Completion date: 2022-04-22
Plan to share individual participant data: NO
Clinical trial NCT05192213: Vitamin C, Hydrocortisone and Thiamine in Patients With Septic Shock
Official title: Vitamin C, Hydrocortisone and Thiamine in Patients With Septic Shock: a Randomized Clinical Study (VITAMIN TRIAL)
Sponsor: Hospital Sirio-Libanes (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: In order to preserve the safety of the patients and prevent any harm from occurring, we opted to discontinue the study based on previous results (LOVIT study) published at 2022. Were recruited 71 than 1090 participants.
Enrollment: 71.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-08-01
Primary completion date: 2022-07-14
Completion date: 2022-09-19
Plan to share individual participant data: NO
IPD sharing description: The study protocol and SAP are not submitted.
Clinical trial NCT04589260: TD-1058 First-In-Human Study in Healthy Subjects and Subjects With Idiopathic Pulmonary Fibrosis
Official title: A Ph 1, Rndmzd, Dbl-Blinded, Pbo-Controlled, 4-Part Study to Eval the Safety, Tolerability, PK, and PD of TD-1058 Admin by Inhalation of Single (A) and Multiple (B) Ascending Doses in Healthy Subjs and Subjs With IPF (C) and Following Admin Microtracer Doses (D)
Sponsor: Theravance Biopharma (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: The Sponsor has decided to stop the study due to business reasons. Study was terminated before initiation of part C and D (Decision to not proceed with Parts C and D was not for safety reasons and do not impact the overall risk benefit of the IMP.)
Enrollment: 72.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-10-15
Primary completion date: 2021-05-06
Completion date: 2021-10-04
Plan to share individual participant data: NO
IPD sharing description: Theravance Biopharma, Inc. will not be sharing individual de-identified participant data or other relevant study documents.
Clinical trial NCT00585195: A Study Of Oral PF-02341066, A C-Met/Hepatocyte Growth Factor Tyrosine Kinase Inhibitor, In Patients With Advanced Cancer
Official title: PHASE 1 SAFETY, PHARMACOKINETIC AND PHARMACODYNAMIC STUDY OF PF-02341066, A MET/HGFR SELECTIVE TYROSINE KINASE INHIBITOR, ADMINISTERED ORALLY TO PATIENTS WITH ADVANCED CANCER
Acronym: PROFILE 1001
Sponsor: Pfizer (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 596.0 (ACTUAL)
Number of arms: 1.0
Start date: 2006-04-19
Primary completion date: 2020-07-30
Completion date: 2022-01-19
Baseline population: Safety analysis (SA) set included all enrolled participants who received at least one dose of Crizotinib on Cycle 1 Day 1.
Plan to share individual participant data: NO
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 NCT03847909: A Study to Evaluate DCR-PHXC in Children and Adults With Primary Hyperoxaluria Type 1 and Primary Hyperoxaluria Type 2
Official title: A Phase 2 Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of DCR-PHXC Solution for Injection (Subcutaneous Use) in Patients With Primary Hyperoxaluria
Acronym: PHYOX2
Sponsor: Novo Nordisk A/S (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 35.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-10-28
Primary completion date: 2021-06-21
Completion date: 2021-06-29
Plan to share individual participant data: NO
Clinical trial NCT04328636: Nebulized MgSO4 in Persistent Pulmonary Hypertension of Newborn
Official title: Nebulized Magnesium Sulfate for Treatment of Persistent Pulmonary Hypertension of The Newborn
Acronym: NebMag
Sponsor: Sohag University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: COMPLETED 
Enrollment: 28.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-11-01
Primary completion date: 2020-07-01
Completion date: 2020-08-01
Clinical trial NCT04274803: Dose Intralipid Infusion Reduces Pregnancy Complications Caused by Antiphospholipid Antibody Syndrome?
Official title: Dose Intralipid Infusion Reduces Pregnancy Complications Caused by Antiphospholipid Antibody Syndrome?
Sponsor: Tanta University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: WITHDRAWN 
Why stopped: no patient enrolled
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-04-01
Primary completion date: 2021-05-31
Completion date: 2021-05-31
Plan to share individual participant data: YES
IPD sharing description: when approved by ethical committee
IPD time frame: 9 months
Clinical trial NCT03970616: A Study of Tivozanib in Combination With Durvalumab in Subjects With Advanced Hepatocellular Carcinoma
Official title: A Phase 1b/2, Open-Label, Study of Tivozanib in Combination With Durvalumab in Subjects With Advanced Hepatocellular Carcinoma
Acronym: DEDUCTIVE
Sponsor: AVEO Pharmaceuticals, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: The study was terminated due to regulatory approval of newer therapeutic options and slower than anticipated accrual.
Enrollment: 27.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-09-30
Primary completion date: 2023-04-04
Completion date: 2023-04-04
Plan to share individual participant data: NO
Clinical trial NCT04523090: Catalysing the Containment of COVID-19
Official title: The C3 Nitazoxanide for Mild to Moderate COVID-19 in HIV-infected and HIV-uninfected Adults With Enhanced Risk: a Double-blind, Randomised, Placebo-controlled Trial in a Resource-poor Setting
Acronym: C3-RCT
Sponsor: University of Cape Town (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: TERMINATED 
Why stopped: Signal of futility at interim analysis
Enrollment: 322.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-08-27
Primary completion date: 2021-12-21
Completion date: 2022-08-12
Clinical trial NCT03865615: Oxytocin on Approach Bias and Craving
Official title: The Effects of Intranasal Oxytocin on Approach Bias and Craving in Moderate to Heavy Alcohol Drinkers
Sponsor: University of California, San Francisco (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: COVID made study visits impossible during the funding period.
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2023-11-01
Primary completion date: 2024-04-20
Completion date: 2024-04-20
Plan to share individual participant data: NO
Clinical trial NCT03729245: A Study of Bempegaldesleukin (NKTR-214: BEMPEG) in Combination With Nivolumab Compared With the Investigator's Choice of a Tyrosine Kinase Inhibitor (TKI) Therapy (Either Sunitinib or Cabozantinib Monotherapy) for Advanced Metastatic Renal Cell Carcinoma (RCC)
Official title: A Phase 3 Randomized Open Label Study to Compare NKTR-214 Combined With Nivolumab to the Investigator's Choice of Sunitinib or Cabozantinib in Patients With Previously Untreated Advanced Renal Cell Carcinoma
Sponsor: Nektar Therapeutics (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Sponsor decision
Enrollment: 623.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-12-18
Primary completion date: 2022-01-07
Completion date: 2022-10-19
Baseline population: A total of 623 patients were randomized in the ITT International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) All-risk population, including 514 patients for the ITT I/P-risk population:~* NKTR-214/nivolumab: 311 and 256, respectively~* Sunitinib or cabozantinib: 312 and 258, respectively
Plan to share individual participant data: UNDECIDED
Clinical trial NCT04627532: Single Ascending Dose Study of Intravenous Infusion of PF 07304814 in Healthy Adult Participants
Official title: A PHASE 1, RANDOMIZED, DOUBLE-BLIND, SPONSOR-OPEN, PLACEBO CONTROLLED, DOSE ESCALATION STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF SINGLE ASCENDING DOSES OF PF-07304814 ADMINISTERED AS A 24-H IV INFUSION IN HEALTHY ADULT PARTICIPANTS
Sponsor: Pfizer (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 16.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-10-23
Primary completion date: 2020-12-17
Completion date: 2020-12-17
Plan to share individual participant data: NO
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 NCT02434965: Autologous Cord Blood and Human Placental Derived Stem Cells in Neonates With Severe Hypoxic-Ischemic Encephalopathy
Official title: A Safety and Feasibility Study of Autologous Cord Blood (CB) and Human Placental Derived Stem Cells (HPDSC) in Neonates With Severe Hypoxic-Ischemic Encephalopathy (HIE)
Acronym: HPDSC+HIE
Sponsor: New York Medical College (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Study not started
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-12-31
Primary completion date: 2021-01-31
Completion date: 2022-01-31
Plan to share individual participant data: NO
IPD sharing description: Study not enrolling
Clinical trial NCT03057977: EMPagliflozin outcomE tRial in Patients With chrOnic heaRt Failure With Reduced Ejection Fraction (EMPEROR-Reduced)
Official title: A Phase III Randomised, Double-blind Trial to Evaluate Efficacy and Safety of Once Daily Empagliflozin 10 mg Compared to Placebo, in Patients With Chronic Heart Failure With Reduced Ejection Fraction (HFrEF)
Sponsor: Boehringer Ingelheim (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 3730.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-03-06
Primary completion date: 2020-05-01
Completion date: 2020-05-28
Baseline population: Randomised Set (RS): All randomised patients.
Clinical trial NCT04590586: Study of Multiple Candidate Agents for the Treatment of COVID-19 in Hospitalized Patients
Official title: Industry Alliance Platform Trial to Assess the Efficacy and Safety of Multiple Candidate Agents for the Treatment of COVID-19 in Hospitalized Patients
Acronym: COMMUNITY
Sponsor: Amgen (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 515.0 (ACTUAL)
Number of arms: 6.0
Start date: 2020-11-24
Primary completion date: 2021-08-03
Completion date: 2021-08-03
Baseline population: Baseline characteristics are reported for the full analysis set, which includes all participants who were randomized to the sub-protocol candidate agent arm as well as all participants who were randomized to any placebo arm included in the control arm of the candidate agent. The Total number of participants (621) includes participants randomized to placebo and included in more than one placebo control group (106 participants); 515 unique participants were enrolled in the study.
Plan to share individual participant data: YES
IPD sharing description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
IPD time frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
IPD access criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
Clinical trial NCT03589976: A Futility Trial of Sirolimus in Multiple System Atrophy
Official title: A Single Center Randomized,Double Blind, Placebo-controlled Futility Trial to Determine if Sirolimus is of Sufficient Promise to Slow the Progression of Multiple System Atrophy
Sponsor: NYU Langone Health (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Interim analysis showed early evidence of futility of sirolimus. Trial stopped per DSMB recommendation.
Enrollment: 47.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-09-01
Primary completion date: 2020-11-20
Completion date: 2021-01-01
Plan to share individual participant data: YES
IPD sharing description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
IPD time frame: Beginning 3 months and ending 5 years following article publication.
IPD access criteria: Researchers who provide a methodologically sound proposal that has been approved by a local Institutional Review Board.
Clinical trial NCT02074436: PRevention Of BLeeding in hEmatological Malignancies With Antifibrinolytic (Epsilon Aminocaproic Acid)
Official title: Randomized Trial of Epsilon Aminocaproic Acid Versus Platelet Transfusions for the Prevention of Bleeding in Thrombocytopenic Patients With Hematological Malignancies
Acronym: PROBLEMA
Sponsor: Emory University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Slow accrual
Enrollment: 29.0 (ACTUAL)
Number of arms: 2.0
Start date: 2014-05-23
Primary completion date: 2020-11-24
Completion date: 2021-05-14
Limitations and caveats: Early termination of the study because of recruitment difficulties lead to insufficient data collection and analysis of primary and secondary outcome measures.
Clinical trial NCT04515329: Tear Film Markers in Dry Eye Syndrome
Official title: Tear Film Markers in Dry Eye Syndrome: Impact of Immunomodulatory Therapy
Sponsor: University of Pittsburgh (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: WITHDRAWN 
Why stopped: No participants were enrolled. Study never started.
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2023-12-08
Primary completion date: 2023-12-08
Completion date: 2023-12-08
Plan to share individual participant data: NO
Clinical trial NCT04629781: Open-label Dose Escalation Phase 1b Trial of a New Micellar Docetaxel Compound in Patients With mCRPC
Official title: Open-label Dose Escalation Phase 1b Trial of a New Micellar Docetaxel Compound in Patients With Metastatic Castration-resistant Prostate Cancer (mCRPC)
Sponsor: Swiss Group for Clinical Cancer Research (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: SAKK decided to premature terminate this trial as additional follow-up visits do not further contribute to the efficacy data. This decision does not adversely impact the patients.
Enrollment: 11.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-05-28
Primary completion date: 2024-01-29
Completion date: 2024-01-29
Clinical trial NCT03357133: Tirofiban for Patients Treated With Alteplase
Official title: A Prospective, Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial of Early Administration of Tirofiban in Acute Ischemic Stroke Patients Treated With Intravenous Alteplase Thrombolysis
Acronym: MR TEA
Sponsor: Capital Medical University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: TERMINATED 
Why stopped: The number and speed of enrollment were significantly less than expected.
Enrollment: 30.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-12-16
Primary completion date: 2020-06-01
Completion date: 2020-08-31
Clinical trial NCT04080908: Study to Assess Feasibility and Safety of Iron Repletion With Feraheme in Iron Deficient Patients With Durable Ventricular Assist Device Support
Official title: Open Label Single Arm Pilot Study to Assess Feasibility and Safety of Iron Repletion With Feraheme in Iron Deficient Patients With Durable Ventricular Assist Device Support
Acronym: AMAGFeraheme
Sponsor: NYU Langone Health (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: Unable to meet enrollment goals.
Enrollment: 1.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-01-15
Primary completion date: 2021-10-19
Completion date: 2021-10-19
Clinical trial NCT03338621: Trial to Evaluate the Efficacy, Safety and Tolerability of BPaMZ in Drug-Sensitive (DS-TB) Adult Patients and Drug-Resistant (DR-TB) Adult Patients
Official title: An Open-Label, Partially Randomized Trial to Evaluate the Efficacy, Safety and Tolerability of a 4-month Treatment of Bedaquiline Plus Pretomanid Plus Moxifloxacin Plus Pyrazinamide (BPaMZ) Compared to a 6-month Treatment of HRZE/HR (Control) in Adult Participants With Drug-Sensitive Smear-Positive Pulmonary Tuberculosis (DS-TB) and a 6-month Treatment of BPaMZ in Adult Participants With Drug Resistant, Smear-Positive Pulmonary Tuberculosis (DR-TB)
Sponsor: Global Alliance for TB Drug Development (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: COMPLETED 
Enrollment: 455.0 (ACTUAL)
Number of arms: 3.0
Start date: 2018-07-30
Primary completion date: 2021-07-01
Completion date: 2022-06-10
Plan to share individual participant data: YES
IPD sharing description: IPD from the trial will be submitted to Critical Path Institute which will make fully anonymized data available through the Tuberculosis Platform for Aggregation of Clinical TB Studies (TB-PACTS) database. Data sets for Drug susceptibility data, Demographic data, MTB diagnostic testing results, Concomitant medications information, Adverse event information, Treatment adherence information, Co-morbidities, Treatment outcomes, HIV co-infection information, CD4 counts, TB disease symptoms from all collected IPD will be made available.
IPD time frame: Data is expected to become available in mid-2024.
IPD access criteria: Researchers must agree to the Terms and Conditions for Use of the TB-PACTS data platform and submit an online application form to request access to the data platform.