At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 372 enrolled
Drug / intervention
Defibrotide +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 3, Randomized, Adaptive Study Comparing the Efficacy and Safety of Defibrotide vs Best Supportive Care in the Prevention of Hepatic Veno-Occlusive Disease in Adult and Pediatric Patients Undergoing Hematopoietic Stem Cell Transplant
In Brief
A Phase 3 clinical trial evaluating Defibrotide and Best Supportive Care for Veno-occlusive Disease. Completed, enrolled 372 participants across 114 sites in 14 countries.
Detailed Summary
This study is to compare the efficacy and safety of defibrotide prophylaxis in addition to best supportive care versus best supportive care alone in the prevention of hepatic veno- occlusive disease (VOD) in adult and pediatric patients undergoing hematopoietic stem cell transplant who are at high risk or very high risk of developing VOD.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsVeno-occlusive Disease
CountriesAustralia, Belgium, Canada, France, Germany, Israel, Italy, Japan, New Zealand, South Korea, Spain, Turkey (Türkiye), United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedAug 2016
Enrollment StartSep 2016
Primary CompletionOct 2020
TodayJul 2026
First PostedAug 1, 2016
Enrollment StartSep 1, 2016
Primary CompletionOct 20, 2020
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 9.9 years ago
Interventions
Defibrotidedrug
Best Supportive Careother