Overview

Defibrotide for the Treatment of Severe Hepatic Veno-Occlusive Disease in Hematopoetic Stem Cell Transplant Patients

Status:
Completed
Trial end date:
2015-03-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 3
Details
Lead Sponsor:
Jazz Pharmaceuticals
Collaborator:
FDA Office of Orphan Products Development
Treatments:
Defibrotide