At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 152 enrolled
Drug / intervention
Defibrotide +1 moredrug
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.
A Phase 2, Prospective, Randomized, Open-Label Study on the Efficacy of Defibrotide Added to Standard of Care Immunoprophylaxis for the Prevention of Acute Graft-versus-Host-Disease in Adult and Pediatric Patients After Allogeneic Hematopoietic Stem Cell Transplant
In Brief
A Phase 2 clinical trial evaluating Defibrotide and Standard of Care for Graft-versus-host Disease and Acute-graft-versus-host Disease. Completed, enrolled 152 participants across 62 sites in 14 countries.
Detailed Summary
This is a study comparing the defibrotide prophylaxis arm vs standard of care arm for the prevention of aGvHD.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustria, Belgium, Bulgaria, Canada, Croatia, France, Germany, Greece, Italy, Poland, Portugal, Spain, United Kingdom, United States
Collaborators--
Timeline
Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedNov 2017
Enrollment StartFeb 2018
Primary CompletionMay 2020
TodayJul 2026
First PostedNov 13, 2017
Enrollment StartFeb 21, 2018
Primary CompletionMay 12, 2020
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 8.6 years ago
Interventions
Defibrotidedrug
6.25 mg/kg via 2-hour IV infusion every 6 hours
Standard of Caredrug
Administered according to local institutional guidelines, physician preference, and patient need.