Defibrotide for the Treatment of Severe Hepatic Veno-Occlusive Disease in Hematopoetic Stem Cell Transplant Patients
Trial ID or NCT#
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.
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
- - Clinical diagnosis of VOD, defined by jaundice (bilirubin >/= 2 mg/dL) and at least 2 of the following clinical findings, by Day+21 post stem cell transplant: ascites; weight gain >/= 5% above baseline weight; hepatomegaly. - Severe VOD, defined as VOD with multi-organ failure, i.e., presence of one or both of the following, by Day+28 post stem cell transplant: renal or pulmonary dysfunction. - Provide voluntary written informed consent.
- - Pre-existing (prior to SCT) cirrhosis - An alternative diagnosis for weight gain, ascites and jaundice - Graft-versus-host disease (GVHD) grade B or higher involving liver or gut or grade C or higher involving skin - Prior solid organ transplant - Dependent on dialysis prior to and/or at the time of SCT - Dependent on oxygen supplementation prior to SCT - Significant acute bleeding or hemodynamic instability - Requirement for the use of any medications that increase risk of hemorrhage will be excluded from the treatment group
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