chufangao/CTO huggingface dataset:
Clinical trial NCT02611323: A Study of Obinutuzumab, Rituximab, Polatuzumab Vedotin, and Venetoclax in Relapsed or Refractory Follicular Lymphoma (FL) or Diffuse Large B-Cell Lymphoma (DLBCL)
Official title: A Phase Ib/II Study Evaluating the Safety and Efficacy of Obinutuzumab in Combination With Polatuzumab Vedotin and Venetoclax in Patients With Relapsed or Refractory Follicular Lymphoma and Rituximab in Combination With Polatuzumab Vedotin and Venetoclax in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma
Sponsor: Hoffmann-La Roche (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: COMPLETED 
Enrollment: 133.0 (ACTUAL)
Number of arms: 4.0
Start date: 2016-03-09
Primary completion date: 2022-08-04
Completion date: 2022-08-04
Baseline population: Safety-evaluable population included all participants who received at least one dose of any component of the combination.
Clinical trial NCT05507996: Recombinant Adeno-associated Virus Administration for Patients With Menkes Syndrome
Official title: An Investigator-initiated Trial Evaluating the Efficacy and Safety of Recombinant Adeno-associated Virus Administration in Patients With Menkes Syndrome
Sponsor: Kunming Hope of Health Hospital (OTHER)
Study type: INTERVENTIONAL
Phase: EARLY_PHASE1
Status: TERMINATED 
Why stopped: The PI decides to stop.
Enrollment: 1.0 (ACTUAL)
Number of arms: 1.0
Start date: 2022-08-18
Primary completion date: 2022-11-23
Completion date: 2022-11-23
Clinical trial NCT04684511: Rofecoxib Efficacy and Safety Evaluation Trial in Hemophilic Arthropathy
Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase III Study With a Long-Term, Open-Label Extension to Evaluate the Efficacy and Safety of TRM-201 (Rofecoxib) in Patients With Hemophilic Arthropathy
Acronym: RESET-HA
Sponsor: Tremeau Pharmceuticals, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Low enrollment. The termination of the trial was not based on any safety concerns in the study.
Enrollment: 2.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-06-02
Primary completion date: 2022-09-28
Completion date: 2022-09-28
Clinical trial NCT04743011: Enriched Heparin Anti COVID-19 Trial
Official title: Nebulized Enriched Heparin to Treat no Critical Patients With Sars-Cov-2 - Triple Blind Clinical Trial
Acronym: EnHanCed
Sponsor: UPECLIN HC FM Botucatu Unesp (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: COMPLETED 
Enrollment: 27.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-06-01
Primary completion date: 2021-11-30
Completion date: 2021-12-31
Plan to share individual participant data: YES
IPD sharing description: There is a plan to make IPD and related data dictionaries available
IPD time frame: The summary data will be published or made available 6 months after publication.
IPD access criteria: Epidemiological data, clinical data, and patient evolution will be shared during the study only for researchers who request access to the data. Access requests will be analyzed by the main researcher, and they will only be released for scientific purposes.
Clinical trial NCT03653364: Study to Assess the Safety, Pharmacokinetics, and Efficacy of Baloxavir Marboxil in Healthy Pediatric Participants From Birth to < 1 Year With Influenza-Like Symptoms
Official title: A Multicenter, Single-Arm, Open-Label Study to Assess the Safety, Pharmacokinetics, and Efficacy of Baloxavir Marboxil in Otherwise Healthy Pediatric Patients From Birth to < 1 Year With Influenza-Like Symptoms
Sponsor: Hoffmann-La Roche (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 49.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-01-23
Primary completion date: 2023-04-03
Completion date: 2023-04-03
Baseline population: Safety-evaluable population included all participants who received at least one dose of treatment regardless of whether they had any follow-up assessments.
Clinical trial NCT03925428: Testing a New Anti-cancer Drug Combination, Entinostat and GSK525762C, for Advanced and Refractory Solid Tumors and Lymphomas
Official title: Phase I Study of GSK525762C and Entinostat in Advanced and Refractory Solid Tumors and Lymphomas
Sponsor: National Cancer Institute (NCI) (NIH)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: Other - Protocol moved to Disapproved
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-09-18
Primary completion date: 2020-09-18
Completion date: 2020-09-18
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 NCT04860466: A Dose Finding Study of CC-96673 in Participants With Relapsed or Refractory Non-Hodgkin's Lymphoma
Official title: A Phase 1, Multicenter, Open-label, Dose Finding Study of CC-96673 in Subjects With Relapsed or Refractory Non-Hodgkin's Lymphoma
Sponsor: Celgene (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Business objectives have changed.
Enrollment: 9.0 (ACTUAL)
Number of arms: 1.0
Start date: 2022-01-20
Primary completion date: 2024-07-31
Completion date: 2024-07-31
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 NCT03706521: A Study Utilizing Imaging Techniques and Evaluating the Safety and Efficacy of SM04690 for the Treatment of Moderately to Severely Symptomatic Knee Osteoarthritis
Official title: A Phase 2, 52 Week, Single Center, Open-Label Study Utilizing Imaging Techniques and Evaluating the Safety and Efficacy of SM04690 Injectable Suspension for the Treatment of Moderately to Severely Symptomatic Knee Osteoarthritis
Sponsor: Biosplice Therapeutics, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: The study was terminated early due to COVID-19-related issues.
Enrollment: 13.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-03-11
Primary completion date: 2020-07-22
Completion date: 2020-12-21
Plan to share individual participant data: NO
Clinical trial NCT05651633: Analgesic Ear Drops for Children With Acute Otitis Media
Official title: Effectiveness of Analgesic Ear Drops as add-on Treatment to Oral Analgesics in Children With Acute Otitis Media: a Pragmatic Randomised Controlled Trial
Acronym: OPTIMA
Sponsor: UMC Utrecht (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Trial accrual problems
Enrollment: 29.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-10-06
Primary completion date: 2023-12-16
Completion date: 2024-01-10
Plan to share individual participant data: YES
IPD sharing description: On completion of the trial, data will be stored for a minimum of 25 years at a central data drive at the Julius Center. The investigators will publish the metadata in the DataverseNL repository and will provide a persistent identifier. The data will be available to researchers who provide a methodologicaly sound proposal to achieve the aims in the approved proposal. Proposals to gain access to the data should be directed to the principle investigator (RPV). Data requestors will need to sign a data sharing agreement.
Clinical trial NCT03450629: Evaluation of Safety and Efficacy of PDP-716
Official title: A Randomized, Multi-Center, Investigator-Masked, Parallel Group, Equivalence Study of Once Daily Brimonidine Tartrate Ophthalmic Suspension Compared With Three Times Daily ALPHAGAN-P® in Subjects With Open Angle Glaucoma, or Ocular Hypertension
Sponsor: Sun Pharma Advanced Research Company Limited (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 682.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-09-13
Primary completion date: 2020-12-01
Completion date: 2020-12-01
Baseline population: Safety Population
Plan to share individual participant data: NO
Clinical trial NCT04418167: JSI-1187-01 Monotherapy and in Combination With Dabrafenib for Advanced Solid Tumors With MAPK Pathway Mutations
Official title: A Phase 1 Study of ERK1/2 Inhibitor JSI-1187 Administered as Monotherapy and in Combination With Dabrafenib for the Treatment of Advanced Solid Tumors With MAPK Pathway Mutations
Sponsor: JS InnoPharm, LLC (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: SUSPENDED 
Why stopped: Sponsor decision
Enrollment: 71.0 (ACTUAL)
Number of arms: 3.0
Start date: 2020-06-18
Primary completion date: 2024-06-30
Completion date: 2024-12-17
Plan to share individual participant data: NO
Clinical trial NCT02891850: Riociguat rEplacing PDE-5i Therapy evaLuated Against Continued PDE-5i thErapy
Official title: A Prospective, Randomized, International, Multicenter, Double-arm, Controlled, Open-label Study of Riociguat in Patients With Pulmonary Arterial Hypertension (PAH) Who Are on a Stable Dose of Phosphodiesterase-5 Inhibitors (PDE-5i) With or Without Endothelin Receptor Antagonist (ERA), But Not at Treatment Goal
Acronym: REPLACE
Sponsor: Bayer (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 225.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-01-11
Primary completion date: 2020-01-29
Completion date: 2020-03-03
Clinical trial NCT03879538: Nitrous Oxide for the Treatment of Complex Regional Pain Syndrome
Official title: A Prospective Randomized Controlled Pilot Study Nitrous Oxide for the Treatment of Complex Regional Pain Syndrome
Sponsor: The Cleveland Clinic (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 44.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-07-02
Primary completion date: 2022-07-28
Completion date: 2022-07-28
Limitations and caveats: limitations include the purely subjective nature of pain which was our primary outcome. Validity of the trial thus depends critically on adequacy of blinding. Because many patients can detect inhaled nitrous oxide, we gave all participants midazolam which has similar effects. But it remains possible that some patients could distinguish nitrous oxide from air, and were thus biased.
Clinical trial NCT03972046: Neoadjuvant Use of Talimogene Laherparepvec and BRAF/MEK Inhibitor for Advanced Nodal BRAF Mutant Melanoma
Official title: Neoadjuvant Use of Talimogene Laherparepvec and BRAF/MEK Inhibitor for Advanced Nodal BRAF Mutant Melanoma: A Pilot Study
Sponsor: TriHealth Inc. (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Principal investigator leaving study site; no replacement PI will be sought
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-06-24
Primary completion date: 2020-02-03
Completion date: 2020-02-03
Plan to share individual participant data: NO
Clinical trial NCT02130557: A Multicenter Phase 3, Open-Label Study of Bosutinib Versus Imatinib in Adult Patients With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia
Official title: A MULTICENTER PHASE 3 RANDOMIZED, OPEN-LABEL STUDY OF BOSUTINIB VERSUS IMATINIB IN ADULT PATIENTS WITH NEWLY DIAGNOSED CHRONIC PHASE CHRONIC MYELOGENOUS LEUKEMIA
Sponsor: Pfizer (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 536.0 (ACTUAL)
Number of arms: 2.0
Start date: 2014-07-15
Primary completion date: 2016-08-11
Completion date: 2020-04-17
Baseline population: Intent-to-treat population: All randomized participants with study drug assignments designated according to initial randomization.
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 NCT05604755: Prophylactic HQP1351 Therapy Post-transplants on Leukemia After Allo-HSCT
Official title: Effect of Prophylactic HQP1351 Maintenance Post-transplants on Ph+ Luekemia Undergoing Allo-HSCT With MRD Positive Pre-transplants
Acronym: Case-Only
Sponsor: Nanfang Hospital, Southern Medical University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Drugs was too expensive eligible for inclusion
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2022-01-01
Primary completion date: 2023-12-30
Completion date: 2024-12-30
Plan to share individual participant data: NO
Clinical trial NCT04359017: Systemic Absorption of Lidocaine After Hematoma Block
Official title: Systemic Absorption of Lidocaine After Ultrasound Guided Hematoma Block for Reduction of Different Types of Pediatric Distal Radius Fractures
Sponsor: Washington University School of Medicine (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: WITHDRAWN 
Why stopped: Sponsoring staff have left institution
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-11-01
Primary completion date: 2023-12-01
Completion date: 2023-12-01
Plan to share individual participant data: NO
Clinical trial NCT03861052: A Study of Tirzepatide (LY3298176) Compared to Dulaglutide in Participants With Type 2 Diabetes
Official title: A Phase 3 Study of Tirzepatide Monotherapy Compared to Dulaglutide 0.75 mg in Patients With Type 2 Diabetes Mellitus
Acronym: SURPASS J-mono
Sponsor: Eli Lilly and Company (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 636.0 (ACTUAL)
Number of arms: 4.0
Start date: 2019-05-07
Primary completion date: 2021-03-10
Completion date: 2021-03-31
Baseline population: All participants who received at least one dose of study drug.
Plan to share individual participant data: YES
IPD sharing description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
IPD time frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
IPD access criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Clinical trial NCT02620306: A Randomized, Double-blind, Active Control, Parallel Group, Titration, Multicenter Study to Evaluate the Efficacy and Safety of Fimasartan
Sponsor: Boryung Pharmaceutical Co., Ltd (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 351.0 (ACTUAL)
Number of arms: 4.0
Start date: 2016-02-11
Primary completion date: 2019-12-23
Completion date: 2022-05-11
Clinical trial NCT04797975: Off-the-shelf NK Cells (KDS-1000) as Immunotherapy for COVID-19
Official title: A Phase 1/2a Multicenter Randomized Double-blind Placebo-controlled Trial of Off-the-shelf Natural Killer Cells (KDS-1000) as Immunotherapy for Adult Patients With Mild to Moderate COVID-19 Symptoms at Risk for Complications
Sponsor: Kiadis Pharma (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: WITHDRAWN 
Why stopped: The sponsor decided to withdraw this study
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-12-31
Primary completion date: 2021-04-30
Completion date: 2021-04-30
Plan to share individual participant data: NO
Clinical trial NCT04435015: The Utility of Camostat Mesylate in Patients With COVID-19 Associated Coagulopathy (CAC) and Cardiovascular Complications
Official title: The Utility of Camostat Mesylate in Patients With COVID-19 Associated Coagulopathy (CAC) and Cardiovascular Complications
Sponsor: Yale University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: WITHDRAWN 
Why stopped: No funding
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-11-30
Primary completion date: 2021-12-31
Completion date: 2021-12-31
Plan to share individual participant data: YES
IPD time frame: Study protocol and clinical study report will be shared 1 year after completion of the study
Clinical trial NCT02966587: Durvalumab in Treating Patients With Metastatic Hormone-Resistant Prostate Cancer
Official title: Durvalumab (MEDI4736) in Hypermutated Metastatic Castration-Resistant Prostate Cancer
Sponsor: University of Washington (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Withdrawn prior to opening to enrollment
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2018-05-15
Primary completion date: 2023-05-15
Completion date: 2023-05-15
Clinical trial NCT04759833: A Study of Prucalopride For Functional Constipation in Children and Teenagers
Official title: Phase 3, Multicenter, Randomized Study With 2 Different Doses of Prucalopride Administered to Male and Female Pediatric Subjects Aged 6 Months to 17 Years With Functional Constipation, Consisting of a 12-week Double-blind, Placebo-controlled Part (Part A) to Evaluate Efficacy and Safety Followed by a 36-week Double-blind Extension Part (Part B) to Document Long-term Safety up to Week 48
Sponsor: Takeda (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Data Monitoring Committee (DMC) decision; terminated due to futility, with no safety concerns; FDA agreement to terminate the study.
Enrollment: 175.0 (ACTUAL)
Number of arms: 5.0
Start date: 2021-07-13
Primary completion date: 2023-11-13
Completion date: 2023-11-13
Baseline population: For Part A, the Safety Analysis Set included all participants who received at least 1 dose of study drug in Part A.
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 NCT02884245: Interest of Estrogen Scheduling Before Ovarian Stimulation With Corifollitropin Alfa
Official title: Interest of Estrogen Scheduling Before Ovarian Stimulation With Corifollitropin Alfa in Women Older Than 38 Years Old Undergoing in Vitro Fertilization
Acronym: PRESCORI
Sponsor: Centre Hospitalier Intercommunal Creteil (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 334.0 (ACTUAL)
Number of arms: 2.0
Start date: 2016-11-04
Primary completion date: 2022-07-01
Completion date: 2023-01-04
Plan to share individual participant data: NO
Clinical trial NCT04941703: CHANGE COVID-19 Severity
Official title: Investigation of Choice Alteration of the Gut Metagenome on COVID-19 Severity
Acronym: CHANGE
Sponsor: Vanderbilt University Medical Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Recruitment issues after COVID-19 abated; not enough hypoxic patients to meet criteria.
Enrollment: 23.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-11-04
Primary completion date: 2022-06-25
Completion date: 2022-06-25
Baseline population: In additional to reporting data for the full trial population we will also report data separately for patients randomized in the ICU (who tend to be more severely ill) and those randomized outside the ICU (who tend to be less severely ill) as well as those with duration of symptoms ≤5 days prior to randomization and those with \>5 days of symptoms prior to randomization.
Clinical trial NCT03931291: APR-246 in Combination With Azacitidine for TP53 Mutated AML (Acute Myeloid Leukemia) or MDS (Myelodysplastic Syndromes) Following Allogeneic Stem Cell Transplant
Official title: Phase II Trial of APR-246 in Combination With Azacitidine as Maintenance Therapy for TP53 Mutated AML or MDS Following Allogeneic Stem Cell Transplant
Sponsor: Aprea Therapeutics (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 33.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-09-16
Primary completion date: 2021-08-27
Completion date: 2022-01-14
Clinical trial NCT04715763: INvestigating TELmisartin Study
Official title: Randomized, Double-Blind, Placebo-Controlled Pilot Clinical Trial of the Safety and Efficacy of Telmisartan for the Treatment of COVID-19 in Hospitalized Patients
Acronym: INTEL
Sponsor: University of Hawaii (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Poor recruitment due to decrease in COVID-19 rates locally
Enrollment: 24.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-09-01
Primary completion date: 2022-04-26
Completion date: 2022-04-26
Plan to share individual participant data: NO
Clinical trial NCT03905512: A Study to Compare the Efficacy of SEL-212 to KRYSTEXXA® in Gout Participants Refractory to Conventional Therapy
Official title: A Study to Compare the Efficacy of SEL-212 to KRYSTEXXA® in Gout Patients Refractory to Conventional Therapy
Acronym: COMPARE
Sponsor: Selecta Biosciences, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 170.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-05-07
Primary completion date: 2020-08-05
Completion date: 2020-08-05
Baseline population: The Intent-to-Treat (ITT) set included all randomized participants.
Plan to share individual participant data: NO
Clinical trial NCT03451695: Effect of Intrathecal Morphine on Chronic Pain After Elective Caesarean Section
Official title: Effect of Intrathecal Morphine on Chronic Pain After Elective Caesarean Section: A Randomized Controlled Trial.
Sponsor: B.P. Koirala Institute of Health Sciences (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 290.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-04-01
Primary completion date: 2020-12-26
Completion date: 2021-03-30
Plan to share individual participant data: YES
IPD sharing description: The final research data will be stored in Mendeley. The final data will be released and shared during the publication process of the manuscript.
IPD time frame: The final research data and study protocol will be shared with the journal accepting the article for publication. It will be available simultaneously after publication of the article.
IPD access criteria: The IPD may be accessed from the link provided in the published manuscript The IPD may also be shared to other researchers by the investigators upon request
Clinical trial NCT02148705: A Study to Evaluate the Efficacy and Safety of NexoBrid in Subjects With Thermal Burns
Official title: A Multicenter, Multinational, Randomized, Controlled, Assessor Blinded Study, Performed in Subjects With Thermal Burns, to Evaluate the Efficacy and Safety of NexoBrid Compared to Gel Vehicle and Compared to Standard of Care
Sponsor: MediWound Ltd (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 175.0 (ACTUAL)
Number of arms: 3.0
Start date: 2015-05-27
Primary completion date: 2018-06-12
Completion date: 2020-08-20
Baseline population: Overall 175 randomized patients are the baseline participants (Full Analysis Set, FAS). Out of the 175, 169 were treated (safety population): 77 In NexoBrid Gel arm, 24 In Gel Vehicle arm (Placebo) and 68 in the SOC arm.