At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 134 enrolled
Drug / intervention
Defibrotidedrug
Likely dose
Defibrotide 6.25 mg/kgfrom 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.
Defibrotide for the Treatment of Severe Hepatic Veno-Occlusive Disease in Hematopoetic Stem Cell Transplant Patients: A Historically-Controlled, Multi-Center Phase 3 Study to Determine Safety & Efficacy
In Brief
A Phase 3 clinical trial evaluating Defibrotide for Severe Hepatic Veno-Occlusive Disease. Completed, enrolled 134 participants across 25 sites in 2 countries.
Detailed Summary
The purpose of this study is to (1) demonstrate the efficacy and safety (toxicity) of 25 mg/kg/day of Defibrotide in patients with severe veno-occlusive disease (sVOD) and (2) evaluate serum and endothelial markers of veno-occlusive disease (VOD) through the analysis of blood samples.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSevere Hepatic Veno-Occlusive Disease
CountriesCanada, United States
CollaboratorsFDA Office of Orphan Products Development
Timeline
Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJul 2006
First PostedAug 2006
Primary CompletionSep 2008
Study CompletionMar 2015
TodayJul 2026
First PostedAug 1, 2006
Enrollment StartJul 1, 2006
Primary CompletionSep 1, 2008
Study CompletionMar 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 19.9 years ago
Interventions
Defibrotidedrug
Defibrotide 6.25 mg/kg i.v. administered four times a day via 2 hour continuous infusion. Minimum duration 21 days.