Trial Search Results
Defibrotide for the Treatment of Severe Hepatic Veno-Occlusive Disease in Hematopoetic Stem Cell Transplant Patients
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.
Stanford is currently not accepting patients for this trial.
Collaborator: FDA Office of Orphan Products Development
- Drug: Defibrotide
- 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
Ages Eligible for Study
N/A - N/A
Genders Eligible for Study