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.

Lead Sponsor:

Jazz Pharmaceuticals

Collaborator: FDA Office of Orphan Products Development

Intervention(s):

  • Drug: Defibrotide

Phase:

Phase 3

Eligibility


Inclusion Criteria:

   - 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.

Exclusion Criteria:

   - 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

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
BMT Referrals
6507230822
Not Recruiting