Defibrotide for Patients With Hepatic Veno-occlusive Disease: A Treatment IND Study
The purpose of this study is to provide Defibrotide to patients diagnosed with VOD. Defibrotide is no longer available though the Emergency Use IND mechanism (also known as compassionate use, or single patient named use). This protocol is the only mechanism by which Defibrotide can be made available to patients in the U.S.
- drug : Defibrotide
Phase: Phase 3
Ages Eligible For Study:
Entry criteria include the following: 1. Clinical diagnosis of VOD, made by Baltimore Criteria, Modified Seattle Criteria, or biopsy proven: 1.1 Baltimore Criteria- Bilirubin ?2 mg/dL and at least 2 of the following clinical findings: - Ascites (radiographic or physical exam) - Weight gain of ?5% compared to the day of conditioning-- if this value is not available, the weight on the date of admission to the SCT unit may be used) - Hepatomegaly; increased over baseline. 1.2 Modified Seattle Criteria: At least two of the following - Bilirubin ?2 mg/dL - Ascites (radiographic or physical exam) and/or weight gain ?5% above baseline weight (defined as weight on the first day of conditioning- if this value is not available, the weight on the date of admission to the SCT unit may be used) - hepatomegaly increased over baseline 1.3 Patients that do not meet the Baltimore Criteria or Modified Seattle Criteria and have biopsy proven VOD are eligible. 2. Patient must also provide written informed consent.