chufangao/CTO huggingface dataset:
Clinical trial NCT04675177: Polidocanol Foam VS Artery Ligation in Hemorrhoidal Disease
Official title: Sclerotherapy With Polidocanol Foam Versus Hemorrhoidal Artery Ligation With Recto Anal Repair in the Treatment of Second and Third-grade Hemorrhoidal Disease: a Prospective Study
Sponsor: Universidade do Porto (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: COMPLETED 
Enrollment: 45.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-09-01
Primary completion date: 2020-02-01
Completion date: 2020-03-25
Plan to share individual participant data: YES
IPD sharing description: Study data can shared upon justified request
IPD time frame: Upon request
IPD access criteria: Justified request (investigation, meta-analysis, medical education)
Clinical trial NCT05682222: Evaluation of the Immunopharmacology of EDP1815 and EDP2939
Official title: A Phase 1, Randomized, Double-blind, Placebo-controlled, Multiple Dose Platform Study Investigating the Immunopharmacology of EDP1815 and EDP2939.
Sponsor: Evelo Biosciences, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 38.0 (ACTUAL)
Number of arms: 4.0
Start date: 2022-06-27
Primary completion date: 2022-10-14
Completion date: 2022-10-14
Plan to share individual participant data: NO
Clinical trial NCT05031481: Efficacy and Safety of Different Doses of Venus Association in Patients With Vulvovaginal Candidiasis.
Official title: National, Multicenter, Randomized, Double-blind, Phase II Clinical Trial to Evaluate the Efficacy and Safety of Different Doses of Venus Association in Patients With Vulvovaginal Candidiasis
Sponsor: EMS (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Sponsor decision
Enrollment: 0.0 (ACTUAL)
Number of arms: 4.0
Start date: 2022-07-01
Primary completion date: 2023-12-31
Completion date: 2024-03-31
Clinical trial NCT05267574: An Open Label, Long Term Safety Study of REN001 in Primary Mitochondrial Myopathy Patients (Stride Ahead)
Official title: An Open-label, Multi-centre Study to Evaluate the Long-term Safety and Tolerability of REN001 in Subjects With Primary Mitochondrial Myopathy (PMM)
Sponsor: Reneo Pharma Ltd (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: TERMINATED 
Why stopped: Parent study failed to show therapeutic effect
Enrollment: 155.0 (ACTUAL)
Number of arms: 1.0
Start date: 2022-02-01
Primary completion date: 2023-12-14
Completion date: 2024-01-31
Clinical trial NCT02742090: Evaluate the Efficacy and Safety of TGR-1202 in Participants With Chronic Lymphocytic Leukemia Who Are Intolerant to Prior Therapy
Official title: A Phase 2 Study to Assess the Safety and Efficacy of TGR-1202 (Umbralisib) in Patients With Chronic Lymphocytic Leukemia (CLL) Who Are Intolerant to Prior BTK or PI3K-Delta Inhibitor Therapy
Sponsor: TG Therapeutics, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: (Strategic/Business Decision)
Enrollment: 51.0 (ACTUAL)
Number of arms: 1.0
Start date: 2016-04-21
Primary completion date: 2021-06-10
Completion date: 2021-06-10
Baseline population: The safety population included all participants who received at least one dose of study treatment.
Limitations and caveats: Due to sponsor's business decision, the clinical trial was terminated by the sponsor prematurely.
Plan to share individual participant data: YES
IPD sharing description: Data will be available upon study closure or as the study evolves
Clinical trial NCT04712006: A Study of JNJ-64304500 Following Subcutaneous Injection in Healthy Chinese Adult Participants
Official title: Phase 1, Open-label, Single Dose Study to Investigate the Pharmacokinetics, Safety, and Tolerability of JNJ-64304500 Following Subcutaneous Injection in Healthy Chinese Adult Participants
Sponsor: Janssen Research & Development, LLC (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: Sponsor Decision.
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-05-30
Primary completion date: 2021-08-27
Completion date: 2021-10-30
Plan to share individual participant data: YES
IPD sharing description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson and Johnson is available at www.janssen.com/clinical- trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) project site at yoda.yale.edu
Clinical trial NCT05048732: Imaging Apoptosis for Lymphoma Treatment Response
Official title: Imaging Apoptosis for Lymphoma Treatment Response
Sponsor: Washington University School of Medicine (OTHER)
Study type: INTERVENTIONAL
Phase: EARLY_PHASE1
Status: TERMINATED 
Why stopped: Futility
Enrollment: 12.0 (ACTUAL)
Number of arms: 3.0
Start date: 2021-12-06
Primary completion date: 2024-02-10
Completion date: 2024-02-10
Plan to share individual participant data: NO
Clinical trial NCT02585258: The Glucocorticoid Low-dose Outcome in RheumatoId Arthritis Study
Official title: The Glucocorticoid Low-dose Outcome in RheumatoId Arthritis Study Comparing the Cost-effectiveness and Safety of Additional Low-dose Glucocorticoid in Treatment Strategies for Elderly Patients With Rheumatoid Arthritis
Acronym: Gloria
Sponsor: Amsterdam UMC, location VUmc (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 451.0 (ACTUAL)
Number of arms: 2.0
Start date: 2016-06-30
Primary completion date: 2020-12-31
Completion date: 2020-12-31
Baseline population: safety population: excludes 2 patients who did not start study medication
Limitations and caveats: Initially slow recruitment, initiatives to enhance recruitment and retention hampered or prohibited by strict and varying ethical guidelines across countries.~The covid-19 pandemic compromised collection of important endpoint data. The pragmatic design caused confounding by treatment changes, most likely reducing the difference in benefit between the groups.~Post-hoc specification of adverse event frequencies done outside of statistical analysis plan.~See reference list (trial results).
Plan to share individual participant data: YES
IPD sharing description: (meta) data will be shared after signing a data sharing agreement, at reasonable cost
IPD time frame: expected active from 2022
IPD access criteria: scientific use
Clinical trial NCT04388761: Feasibility and Safety of Allogeneic Adipose Mesenchymal Stem Cells (aMSCs) Delivery Into Kidney Allografts Procured From Deceased Donors With High Kidney Donor Profile Index (KDPI)
Official title: Feasibility and Safety of Allogeneic Adipose Mesenchymal Stem Cells (aMSCs) Delivery Into Kidney Allografts Procured From Deceased Donors With High Kidney Donor Profile Index (KDPI)
Sponsor: Mayo Clinic (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: Challenges in recruiting participants.
Enrollment: 0.0 (ACTUAL)
Number of arms: 3.0
Start date: 2020-09-30
Primary completion date: 2024-02-29
Completion date: 2024-02-29
Plan to share individual participant data: NO
Clinical trial NCT01333033: PET Scan Imaging in Assessing Response in Patients With Esophageal Cancer Receiving Combination Chemotherapy
Official title: Randomized Phase II Trial of PET Scan-Directed Combined Modality Therapy in Esophageal Cancer
Sponsor: Alliance for Clinical Trials in Oncology (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 257.0 (ACTUAL)
Number of arms: 2.0
Start date: 2011-07-31
Primary completion date: 2015-11-30
Completion date: 2023-04-01
Baseline population: All participants who enrolled on this trial are included in this analysis.
Clinical trial NCT04262375: A Phase 2 Study of Durvalumab (MEDI4736) and Oleclumab (MEDI9447) in Multi-Cancer Populations With Correlation to Clinical, Molecular and Immunologic Parameters With DNA MethylaTION
Official title: A Phase 2 Study of Durvalumab (MEDI4736) and Oleclumab (MEDI9447) in Multi-Cancer Populations With Correlation to Clinical, Molecular and Immunologic Parameters With DNA MethylaTION (DOMINATION)
Acronym: DOMINATION
Sponsor: University Health Network, Toronto (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Overall clinical activity (ORR) for oleclumab + durvalumab is minimal across tumor types and does not support further evaluation of this doublet.
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-01-31
Primary completion date: 2024-01-31
Completion date: 2024-01-31
Plan to share individual participant data: NO
Clinical trial NCT04614974: Initiation of Acid Suppression Therapy Prospective Outcomes for Laryngomalacia
Official title: Initiation of Acid Suppression Therapy Prospective Outcomes for Laryngomalacia
Sponsor: University of Pittsburgh (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Slow recruitment due to few eligible patients
Enrollment: 65.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-11-18
Primary completion date: 2024-05-17
Completion date: 2024-05-17
Plan to share individual participant data: NO
Clinical trial NCT04865159: Cardiovascular Safety Study of Tipifarnib in Patients With Advanced Solid Malignancies
Official title: A Phase I, Open-label Clinical Pharmacology Study to Evaluate the Effect of Tipifarnib on Cardiac Safety in Subjects With Advanced Solid Malignancies
Sponsor: Kura Oncology, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Study terminated due to recruitment challenges
Enrollment: 6.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-05-06
Primary completion date: 2023-05-02
Completion date: 2023-05-02
Plan to share individual participant data: NO
Clinical trial NCT02100956: Efficacy of Intrathecal Oxytocin in Patients With Neuropathic Pain
Official title: Efficacy of Intrathecal Oxytocin in Patients With Neuropathic Pain
Sponsor: Wake Forest University Health Sciences (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Cessation of funding period prior to completion, due to slow recruitment during the pandemic
Enrollment: 8.0 (ACTUAL)
Number of arms: 2.0
Start date: 2014-06-19
Primary completion date: 2022-10-10
Completion date: 2022-10-10
Limitations and caveats: This study was terminated early due to slow recruitment and lack of funding.
Clinical trial NCT05757492: Study to Evaluate Safety and PK of CHS-006 in Combination With Toripalimab in Patients With Advanced Solid Tumors
Official title: A Phase 1, Multicenter, Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of CHS-006, as Monotherapy and in Combination With Toripalimab, in Participants With Advanced Solid Tumors
Sponsor: Coherus Biosciences, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: The study was terminated for strategic reasons (not for safety concerns)
Enrollment: 22.0 (ACTUAL)
Number of arms: 4.0
Start date: 2023-04-26
Primary completion date: 2024-07-31
Completion date: 2024-07-31
Clinical trial NCT05124691: Evaluation of Effectiveness of ALBENDAZOLIVERMECTIN Coformulation vs ALBENDAZOLE for Treatment of Intestinal Worms
Official title: An Adaptive Phase II/III SingleBlinded, Randomized, MultiCentre, ParallelGroup, Active Controlled, Superiority Study to Evaluate the Safety and Efficacy of a Single Day or 3day Single Dose of an ALBENDAZOLE IVERMECTIN Coformulation vs ALBENDAZOLE for the Treatment of SoilTransmitted Helminth Infections (Trichuris Trichiura, Hookworm, Strongyloides Stercoralis) in Paediatric and Young Adult Population
Acronym: ALIVE
Sponsor: Barcelona Institute for Global Health (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: TERMINATED 
Why stopped: Primary Endpoint met
Enrollment: 992.0 (ACTUAL)
Number of arms: 3.0
Start date: 2022-01-20
Primary completion date: 2023-03-21
Completion date: 2023-03-24
Plan to share individual participant data: YES
IPD sharing description: All data from the ALIVE clinical trial (phase II and phase III) have been upload to the Infectious Diseases Data Observatory (IDDO). IDDO is a scientifically independent, multi-disciplinary coalition of the global infectious disease and emerging infections communities. Thus, data will be available upon request in a collaborative data repository for verification and re-use.
IPD time frame: Data is already available upon request to IDDO
IPD access criteria: All data sharing request received by IDDO will be addressed to the project consortium members who will approve/reject the data sharing based on the relevance of the proposal.
Clinical trial NCT03834584: A Study of AG-636 in the Treatment of Subjects With Advanced Lymphoma
Official title: A Phase 1 Study of AG-636 in the Treatment of Subjects With Advanced Lymphoma
Sponsor: Agios Pharmaceuticals, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Terminated due to sponsor decision.
Enrollment: 11.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-05-24
Primary completion date: 2020-06-17
Completion date: 2020-06-17
Plan to share individual participant data: NO
Clinical trial NCT03849365: Study of Erectile Dysfunction, Urinary Incontinence and Related QoL After TOOKAD® VTP for Low Risk Prostate Cancer
Official title: Study of Erectile Dysfunction, Urinary Incontinence and Related Quality of Life After TOOKAD® Vascular Targeted Photodynamic Therapy (VTP) for Minimally Invasive Treatment of Unilateral Low Risk Prostate Cancer
Sponsor: Steba Biotech S.A. (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: Early end of enrolment with regards to difficulty met to enrol patients
Enrollment: 23.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-01-21
Primary completion date: 2020-11-13
Completion date: 2020-11-13
Plan to share individual participant data: NO
Clinical trial NCT05216614: Fluvoxamine to Augment Olfactory Recovery For Long COVID-19 Parosmia
Official title: Fluvoxamine to Augment Olfactory Recovery For Long COVID-19 Parosmia (FluCOP Trial)
Acronym: FluCOP
Sponsor: Washington University School of Medicine (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Unable to obtain investigational product
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-12-14
Primary completion date: 2022-02-22
Completion date: 2022-02-22
Plan to share individual participant data: NO
Clinical trial NCT04104646: CHF6563 in Babies With Neonatal Opioid Withdrawal Syndrome
Official title: A Phase II, Multicenter, Double Blind, Double Dummy, Randomized, 2 Arms Parallel Study to Evaluate the Efficacy, Safety and Pharmacokinetics of CHF6563 in Babies With Neonatal Opioid Withdrawal Syndrome
Acronym: NOWSHINE
Sponsor: Chiesi Farmaceutici S.p.A. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Low recruitment rate
Enrollment: 7.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-12-18
Primary completion date: 2021-12-13
Completion date: 2021-12-13
Limitations and caveats: The study objectives could not be addressed because the study was terminated due to a low recruitment; for non-safety reasons.~Despite concerted efforts by the Sponsor to improve the enrolment rate (e.g., through communications with the Investigators, changing the training modalities to meet nurses' requests, and decreasing the sample size), the projected time frame to complete the study was longer than 5 years; this was considered unacceptable for the clinical development programme.
Plan to share individual participant data: NO
Clinical trial NCT04947579: A Study of CC-99677 in Participants With Active Ankylosing Spondylitis
Official title: A Phase 2 Multicenter, Randomized, Double-Blinded, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of CC-99677 in Subjects With Active Ankylosing Spondylitis
Acronym: AS SpA axSpA
Sponsor: Celgene (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: The study has been terminated due to Non-Safety reasons because of lack of efficacy in the short-term acute phase.
Enrollment: 167.0 (ACTUAL)
Number of arms: 6.0
Start date: 2021-08-25
Primary completion date: 2023-02-21
Completion date: 2023-02-21
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 NCT04820842: A Study of TAK-994 in Adults With Narcolepsy
Official title: A Dose-Blind Extension Study With Double-blind, Placebo-Controlled, Randomized Withdrawal Period to Evaluate the Safety and Explore the Pharmacokinetics and Pharmacodynamics of TAK-994 in Adults With Narcolepsy With Cataplexy (Narcolepsy Type 1)
Sponsor: Takeda (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: A safety signal has emerged in Phase 2 studies of TAK-994. As an immediate precautionary measure, Takeda has suspended dosing of patients and has decided to stop Phase 2 studies early.
Enrollment: 26.0 (ACTUAL)
Number of arms: 7.0
Start date: 2021-04-30
Primary completion date: 2021-11-03
Completion date: 2021-11-03
Baseline population: Safety Analysis Set for the Active Drug Extension Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period.
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 NCT01895075: Inhaled Budesonide for Non-ventilated Infants at High Risk of Bronchopulmonary Dysplasia: the i-BUD Pilot Study
Official title: Evaluation of the Effectiveness of Inhaled Budesonide for Non-ventilated Infants at High Risk of Bronchopulmonary Dysplasia: the i-BUD Pilot Study
Sponsor: Sunnybrook Health Sciences Centre (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Insufficient funding
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-01-01
Primary completion date: 2020-07-01
Completion date: 2020-09-01
Plan to share individual participant data: NO
Clinical trial NCT03943342: Ibrutinib and Venetoclax in Treating Patients With Chronic Lymphocytic Leukemia After Ibrutinib Resistance
Official title: A Multicenter Study of Ibrutinib Resistance Development and Intervention With Venetoclax (Phase II)
Sponsor: Ohio State University Comprehensive Cancer Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Study not feasible
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-03-11
Primary completion date: 2021-07-20
Completion date: 2021-07-20
Plan to share individual participant data: NO
Clinical trial NCT02867904: Intra-Operative Corticosteroid Injection During Arthroscopic Shoulder Surgery
Official title: Efficacy of Intra-operative Subacromial Corticosteroid Injections on Surgical Outcomes After Arthroscopic Shoulder Surgery
Sponsor: University of South Dakota (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: It was difficult to recruit patients to get the appropriate sample size.
Enrollment: 12.0 (ACTUAL)
Number of arms: 2.0
Start date: 2016-03-31
Primary completion date: 2020-04-30
Completion date: 2020-04-30
Clinical trial NCT03522584: Durvalumab, Tremelimumab and Hypofractionated Radiation Therapy in Treating Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
Official title: Durvalumab (MEDI4736), Tremelimumab and Palliative Hypofractionated Image Guided Radiation Therapy (HIGRT) in Patients With Recurrent/Metastatic Squamous Cell Carcinomas of the Head and Neck Previously Treated With Immune Checkpoint Inhibitors
Sponsor: University of Washington (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Terminated by the sponsor due to lack of efficacy in study treatment.
Enrollment: 6.0 (ACTUAL)
Number of arms: 1.0
Start date: 2018-05-17
Primary completion date: 2021-12-16
Completion date: 2022-01-19
Plan to share individual participant data: NO
Clinical trial NCT02349633: Study For Patients With NSCLC EGFR Mutations (Del 19 or L858R +/- T790M)
Official title: PHASE 1/2 OPEN-LABEL STUDY OF PF-06747775 (EPIDERMAL GROWTH FACTOR RECEPTOR T790M INHIBITOR) IN PATIENTS WITH ADVANCED EPIDERMAL GROWTH FACTOR RECEPTOR MUTANT (DEL 19 OR L858R ± T790M) NON-SMALL CELL LUNG CANCER
Sponsor: Pfizer (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: The study was ended for strategic reasons and changes in the external environment.~The safety profile and risk benefit ratio for PF-0674775 remained unchanged.
Enrollment: 65.0 (ACTUAL)
Number of arms: 4.0
Start date: 2015-05-14
Primary completion date: 2020-05-28
Completion date: 2020-05-28
Baseline population: Participants with advanced epidermal growth factor receptor mutant (EGFRm) non-small cell lung cancer (NSCLC) were enrolled in this study. The safety analysis set included all enrolled patients who received at least 1 dose of study treatment. No enrollments occurred in Phase 1 Food Effect and Rifampin DDI sub-study, Phase 2 Cohort 2B or Phase 1b Cohort 3 prior to study termination.
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 NCT04183790: Evaluation of Long-term Safety and Efficacy of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are 6 Years of Age and Older
Official title: A Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-445/TEZ/IVA Combination Therapy in Subjects With Cystic Fibrosis Who Are 6 Years of Age and Older
Sponsor: Vertex Pharmaceuticals Incorporated (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 64.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-02-17
Primary completion date: 2024-02-24
Completion date: 2024-02-24
Plan to share individual participant data: NO
IPD sharing description: Details on Vertex data sharing criteria and process for requesting access can be found at: https://www.vrtx.com/independent research/clinical-trial-data-sharing
Clinical trial NCT04622111: Safety and Pharmacokinetics Study of CPL207280 Compound in Healthy Volunteers.
Official title: One Centre, Single Ascending Dose and Double Blind Multiple Ascending Dose, Safety and Pharmacokinetics Phase I Study of CPL207280 Compound in Healthy Volunteers.
Sponsor: Celon Pharma SA (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 68.0 (ACTUAL)
Number of arms: 3.0
Start date: 2020-05-27
Primary completion date: 2021-04-01
Completion date: 2021-05-05