chufangao/CTO huggingface dataset:
Clinical trial NCT04659109: Glenzocimab in SARS-Cov-2 Acute Respiratory DistrEss syNdrome Related to COVID-19
Official title: A Randomized, Double Blind, Multicenter, Placebo Controlled, Parallel Group, Exploratory Efficacy and Safety Study of Glenzocimab in SARS-Cov-2-related Acute Respiratory Distress Syndrome
Acronym: GARDEN
Sponsor: Acticor Biotech (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 60.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-12-16
Primary completion date: 2021-08-06
Completion date: 2021-08-06
Plan to share individual participant data: NO
Clinical trial NCT03328936: Study of Personalized Melphalan Dosing in the Setting of Autologous Transplant
Official title: Randomized Study of Personalized Melphalan Dosing in the Setting of Autologous Transplant
Sponsor: Ohio State University Comprehensive Cancer Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Sponsor decision
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-09-01
Primary completion date: 2021-03-31
Completion date: 2021-03-31
Clinical trial NCT05193279: Safety and Immunogenicity of SCB-2019 in Children <18 Years of Age
Official title: A Randomized, Controlled, Dose-finding, Observer-blind, Phase 2/3 Study to Evaluate the Safety, Reactogenicity and Immunogenicity of CpG/Alum-adjuvanted Recombinant SARS-CoV-2 Trimeric S-protein Subunit Vaccines (SCB-2019 Vaccine) in Children <18 Years of Age
Sponsor: Clover Biopharmaceuticals AUS Pty Ltd (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: WITHDRAWN 
Why stopped: The study was terminated during the EC submission process prior to the enrollment.
Enrollment: 0.0 (ACTUAL)
Number of arms: 21.0
Start date: 2022-10-05
Primary completion date: 2022-12-15
Completion date: 2022-12-15
Clinical trial NCT03151057: Idelalisib Post Allogeneic Hematopoietic Stem Cell Transplant (HSCT) in B Cell Derived Malignancies
Official title: Idelalisib Post Allogeneic Hematopoietic Stem Cell Transplant (HSCT) in B Cell Derived Malignancies: A Phase 1 Double Blinded Randomized Placebo Toxicity Trial
Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Safety endpointreached
Enrollment: 16.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-07-31
Primary completion date: 2022-06-20
Completion date: 2022-07-20
Plan to share individual participant data: NO
Clinical trial NCT04084483: A Study Assessing the Safety, Efficacy, and Optimum Dosage of K-161 in Subjects With Moderate to Severe Dry Eye Disease
Official title: A Study Assessing the Safety, Efficacy, and Optimum Dosage of K-161 in Subjects With Moderate to Severe Dry Eye Disease
Sponsor: Kowa Research Institute, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 238.0 (ACTUAL)
Number of arms: 4.0
Start date: 2019-08-04
Primary completion date: 2020-01-09
Completion date: 2020-01-09
Clinical trial NCT04335578: A Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Zampilimab in Adult Kidney Transplant Recipients With Chronic Allograft Injury
Official title: A Multicenter, Randomized, Placebo-Controlled Investigator-Blind, Participant-Blind Study to Evaluate Safety/Tolerability, Pharmacokinetics, and Pharmacodynamics of Zampilimab in Adult Kidney Transplant Recipients With Chronic Allograft Injury
Sponsor: UCB Pharma (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Recruitment challenges
Enrollment: 3.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-10-21
Primary completion date: 2022-05-04
Completion date: 2022-05-04
Plan to share individual participant data: NO
IPD sharing description: Due to the small sample size in this trial, IPD cannot be adequately anonymized i.e., there is a reasonable likelihood that individual participants could be re-identified. For this reason, data from this trial cannot be shared.
Clinical trial NCT04642950: A Phase II/III Study of Sargramostim
Official title: A Phase II/III Study of Sargramostim in Patients With Coronavirus Disease-2019 (COVID-19)
Sponsor: Nobelpharma (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: COMPLETED 
Enrollment: 70.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-12-17
Primary completion date: 2021-10-25
Completion date: 2021-10-25
Plan to share individual participant data: NO
Clinical trial NCT02920996: Merestinib In Non-Small Cell Lung Cancer And Solid Tumors
Official title: A Phase II Study of Merestinib in Non-Small Cell Lung Cancers Harboring MET Exon 14 Mutations and Solid Tumors With NTRK Rearrangements
Sponsor: Dana-Farber Cancer Institute (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Funding was pulled
Enrollment: 12.0 (ACTUAL)
Number of arms: 2.0
Start date: 2016-11-11
Primary completion date: 2021-10-31
Completion date: 2023-10-31
Baseline population: No patient was accrued in the solid tumor arm.
Plan to share individual participant data: NO
Clinical trial NCT02927301: A Study of Atezolizumab as Neoadjuvant and Adjuvant Therapy in Resectable Non-Small Cell Lung Cancer (NSCLC) - Lung Cancer Mutation Consortium (LCMC3)
Official title: A Phase II, Open-Label, Multicenter, Single-Arm Study to Investigate the Efficacy and Safety of Atezolizumab as Neoadjuvant and Adjuvant Therapy in Patients With Stage IB, II, IIIA, or Selected IIIB Resectable and Untreated Non-Small Cell Lung Cancer
Sponsor: Genentech, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 181.0 (ACTUAL)
Number of arms: 1.0
Start date: 2017-04-20
Primary completion date: 2020-05-07
Completion date: 2023-09-05
Baseline population: Safety population included all enrolled participants who have received any dose of study drug.
Clinical trial NCT04712071: Ketamine in Veterans With Gulf War Illness
Official title: Effects of a Single Dose of Intravenous Ketamine on Symptoms of Gulf War Illness in 1990-1991 Gulf War Veterans
Sponsor: Baylor College of Medicine (OTHER)
Study type: INTERVENTIONAL
Phase: EARLY_PHASE1
Status: TERMINATED 
Why stopped: Due to the COVID pandemic we could not enroll more than one subject before funding was ending.
Enrollment: 1.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-02-01
Primary completion date: 2022-02-16
Completion date: 2022-02-16
Plan to share individual participant data: NO
IPD sharing description: We have not decided yet what the best way is to share the data. The data will become available, though.
Clinical trial NCT03472365: A Study of SHR-1210 in Combination With Capecitabine + Oxaliplatin or Apatinib in Treatment of Advanced Gastric Cancer
Official title: A Randomized Phase 2 Study to Evaluate Safety and Efficacy of the Combination of SHR-1210 With Capecitabine + Oxaliplatin or Apatinib as First-line Treatment in Patients With Advanced Gastric or Gastroesophageal Junction Adenocarcinoma
Sponsor: Jiangsu HengRui Medicine Co., Ltd. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 67.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-04-02
Primary completion date: 2020-11-25
Completion date: 2020-11-25
Plan to share individual participant data: UNDECIDED
Clinical trial NCT03627091: Efficacy and Safety Study of Ontamalimab as Maintenance Treatment in Participants With Moderate to Severe Crohn's Disease (CARMEN CD 307)
Official title: A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Maintenance Therapy in Subjects With Moderate to Severe Crohn's Disease (CARMEN CD 307)
Acronym: CARMEN CD 307
Sponsor: Takeda (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Sponsor decision to discontinue the SHP647 (ontamalimab) clinical trial development program for inflammatory bowel diseases (IBD) early.
Enrollment: 40.0 (ACTUAL)
Number of arms: 3.0
Start date: 2019-02-06
Primary completion date: 2021-06-21
Completion date: 2021-09-13
Baseline population: The safety set consisted of all participants who have received at least one dose of investigational product (IP) in the SHP647-307 study regardless of treatment received during the induction studies (either SHP647-305 \[NCT03559517\] or SHP647-306 \[NCT03566823\]).
Limitations and caveats: The study was closed early as the sponsor discontinued the ontamalimab clinical trial program in CD for reasons unrelated to safety or efficacy.
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 NCT05170009: Baloxavir in Combination With Oseltamivir in Allogenic Bone Marrow Transplant Recipients With Influenza
Official title: Randomized Double-blind, Placebo-controlled Single Center Pilot Study to Evaluate the Efficacy and Safety of Baloxavir in Combination With Oseltamivir in Adult Allogeneic Bone Marrow Transplant Recipients With Influenza
Sponsor: Weill Medical College of Cornell University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: TERMINATED 
Why stopped: Slow enrollment rate
Enrollment: 2.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-04-22
Primary completion date: 2024-01-17
Completion date: 2024-02-07
Plan to share individual participant data: NO
Clinical trial NCT04869982: Efficacy, Immunogenicity and Safety Study of GSKs Recombinant Zoster Vaccine Shingrix (GSK1437173A) in Chinese Adults Aged ≥50 Years
Official title: A Phase IV, Randomized, Observer-blind, Placebo-controlled, Multi-center Study to Assess the Prophylactic Efficacy Against Herpes Zoster, Immunogenicity and Safety of Shingrix When Administered Intramuscularly on a 2-dose Schedule in Chinese Adults Aged 50 Years and Older
Sponsor: GlaxoSmithKline (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 6138.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-05-14
Primary completion date: 2023-04-20
Completion date: 2023-04-20
Plan to share individual participant data: YES
IPD sharing description: IPD for this study will be made available via the Clinical Study Data Request site.
IPD time frame: IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.
IPD access criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
Clinical trial NCT02939807: A Phase II Study of ABC294640 As Monotherapy in Patients with Advanced Hepatocellular Carcinoma
Official title: A Phase II Study of ABC294640 in Patients with Advanced Hepatocellular Carcinoma Who Have Progressed on Sorafenib
Sponsor: Medical University of South Carolina (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: study is being rewritten for different disease population
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-09-30
Primary completion date: 2023-09-30
Completion date: 2024-01-30
Plan to share individual participant data: NO
Clinical trial NCT02834611: Ceramide NanoLiposome in Patients With Advanced Solid Tumors
Official title: Phase I Study of C6 Ceramide NanoLiposome in Patients With Advanced Solid Tumors
Sponsor: Keystone Nano, Inc (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 14.0 (ACTUAL)
Number of arms: 1.0
Start date: 2017-03-15
Primary completion date: 2023-08-03
Completion date: 2023-11-01
Clinical trial NCT03744910: Clazakizumab for the Treatment of Chronic Active Antibody Mediated Rejection in Kidney Transplant Recipients
Official title: A Pivotal Phase 3 Trial to Evaluate the Safety and Efficacy of Clazakizumab for the Treatment of Chronic Active Antibody-mediated Rejection in Kidney Transplant Recipients
Acronym: IMAGINE
Sponsor: CSL Behring (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Early stop for lack of efficacy/futility (at Interim analysis)
Enrollment: 194.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-10-14
Primary completion date: 2024-04-08
Completion date: 2024-04-08
Clinical trial NCT03471078: Avatrombopag for the Treatment of Chemotherapy-Induced Thrombocytopenia in Adults With Active Non-Hematological Cancers
Official title: Randomized, Double-Blind, Placebo-Controlled Study With Open-Label Extension to Evaluate the Efficacy and Safety of Avatrombopag for the Treatment of Chemotherapy-Induced Thrombocytopenia in Subjects With Active Non-Hematological Cancers
Sponsor: Sobi, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 122.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-10-12
Primary completion date: 2020-08-28
Completion date: 2023-01-31
Clinical trial NCT04471714: Effects of Baclofen on Presynaptic Inhibition in Humans
Official title: Effects of Baclofen on Presynaptic Inhibition in Humans
Sponsor: University of Alberta (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Study recruitment was halted due to restrictions and we have decided to not pursue it further.
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-01-10
Primary completion date: 2022-03-17
Completion date: 2022-03-17
Plan to share individual participant data: YES
IPD sharing description: De-identified individual participant data will be available to other researchers upon that researchers request.
IPD time frame: Upon completion of the study (TBD).
IPD access criteria: IPD will be provided to researchers who have contacted the primary investigator and requested additional data. All data will be de-identified.
Clinical trial NCT03639311: Phase 2b, Open-label, Multicenter, Rollover Study to Assess Antiviral Activity and Safety of Long-acting (LA) Cabotegravir (CAB) Plus LA Rilpivirine (RPV), Administered Every 2 Months (Q2M), in Human Immunodeficiency Virus (HIV)-Positive Participants From the LATTE Study
Official title: A Phase IIb, Multicenter, Open-label, Rollover Study Evaluating the Efficacy, Safety and Tolerability of Long-acting Cabotegravir Plus Long-acting Rilpivirine Administered Every Two Months in HIV-1 Infected Adults Who Are Virologically Suppressed and Participated in Study LAI116482
Sponsor: ViiV Healthcare (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 97.0 (ACTUAL)
Number of arms: 3.0
Start date: 2018-09-24
Primary completion date: 2019-12-11
Completion date: 2023-01-30
Plan to share individual participant data: YES
IPD sharing description: IPD for this study will be made available via the Clinical Study Data Request site.
IPD time frame: IPD will be made available, within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.
IPD access criteria: Access is provided, after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided, for an initial period of 12 months but an extension can be granted, when justified for up to another 12 months.
Clinical trial NCT03747939: Efficacy, Safety, and Tolerability Study of Apremilast to Treat Early Oligoarticular Psoriatic Arthritis.
Official title: A Phase 4, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Apremilast (CC-10004) in Subjects With Early, Oligoarticular Psoriatic Arthritis Despite Initial Stable Treatment With Either NSAIDS and/or ≤ 1 Conventional Synthetic DMARD
Acronym: FOREMOST
Sponsor: Amgen (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 310.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-12-31
Primary completion date: 2022-12-19
Completion date: 2023-07-05
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 NCT03112681: Study to Evaluate Safety, Tolerability and Efficacy of Saroglitazar Mg in Patients With Primary Biliary Cholangitis
Official title: A Phase 2, Prospective, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate Safety, Tolerability and Efficacy of Saroglitazar Magnesium in Patients With Primary Biliary Cholangitis (EPICS )
Acronym: EPICS
Sponsor: Zydus Therapeutics Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 37.0 (ACTUAL)
Number of arms: 3.0
Start date: 2017-08-18
Primary completion date: 2020-08-07
Completion date: 2020-08-07
Clinical trial NCT04060147: Safety and Tolerability of Cilofexor in Participants With Primary Sclerosing Cholangitis (PSC) and Compensated Cirrhosis
Official title: A Proof-of-Concept, Open-Label Study Evaluating the Safety and Tolerability of Cilofexor in Subjects With Primary Sclerosing Cholangitis (PSC) and Compensated Cirrhosis
Sponsor: Gilead Sciences (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: The study enrollment was terminated early by the sponsor due to recruitment challenges.
Enrollment: 11.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-10-17
Primary completion date: 2021-09-02
Completion date: 2021-09-02
Baseline population: Safety Analysis Set included all participants who took at least 1 dose of study drug.
Plan to share individual participant data: NO
Clinical trial NCT05177588: Efficacy of Metformin as add-on Therapy in Non-Diabetic Heart Failure Patients
Official title: Efficacy of Metformin as add-on Therapy in Non-Diabetic Heart Failure Patients
Sponsor: Cairo University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 70.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-07-21
Primary completion date: 2023-03-30
Completion date: 2023-04-30
Plan to share individual participant data: NO
Clinical trial NCT03971825: A Safety Study of CC-92252 in Healthy Adult Subjects and Adult Subjects With Psoriasis
Official title: A Phase 1, Randomized, 3-Part Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Ascending Doses of CC-92252 in Healthy Adult Subjects and Adult Subjects With Psoriasis.
Sponsor: Celgene (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Did not meet progression criteria
Enrollment: 131.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-07-24
Primary completion date: 2021-08-05
Completion date: 2021-08-05
Plan to share individual participant data: YES
IPD sharing description: Information relating to our policy on data sharing and the process for requesting data can be found at the following link:~https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/
IPD time frame: See Plan Description
IPD access criteria: See Plan Description
Clinical trial NCT02435212: Study to Evaluate Treatment Compliance, Efficacy and Safety of an Improved Deferasirox Formulation (Granules) in Pediatric Patients (2-<18 Years Old) With Iron Overload
Official title: A Randomized, Open-label, Multicenter, Two Arm, Phase II Study to Evaluate Treatment Compliance, Efficacy and Safety of an Improved Deferasirox Formulation (Granules) in Pediatric Patients With Iron Overload
Sponsor: Novartis (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 224.0 (ACTUAL)
Number of arms: 2.0
Start date: 2015-10-21
Primary completion date: 2018-05-31
Completion date: 2024-01-15
Baseline population: Full Analysis Set (FAS) was defined according to the Intent to Treat (ITT) principle, and included all randomized participants.
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 NCT03597347: Trial of Inhaled Molgramostim in Cystic Fibrosis Subjects With Nontuberculous Mycobacterial Infection
Official title: An Open-label, Non-controlled, Multicenter, Pilot Trial, Using Inhaled Molgramostim in Cystic Fibrosis Subjects With Nontuberculous Mycobacterial (NTM) Infection
Acronym: ENCORE
Sponsor: Savara Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Recruitment for trial stopped early due to limitations from COVID-19, additionally changes in the standard of care for CF patients during the study period resulted in confounding of the primary endpoint.
Enrollment: 14.0 (ACTUAL)
Number of arms: 3.0
Start date: 2019-06-20
Primary completion date: 2020-10-02
Completion date: 2020-10-02
Limitations and caveats: Due to the early termination of the study, some specified endpoints had insufficient data to be analyzed:~\* Durable NTM sputum smear conversion to negative without subsequent positive smears at Week 12 after End of Treatment (EOT).~Change from Baseline to EOT and Week 12 after EOT in:~* semi-quantitative grade of number of NTM on microscopy of AFB stained sputum smears~* FEV1 (percent predicted)~* respiratory domain score assessed by CFQ-R~* body mass index
Plan to share individual participant data: NO