Status:
COMPLETED
Defibrotide for the Treatment of Severe Hepatic Veno-Occlusive Disease in Hematopoetic Stem Cell Transplant Patients
Lead Sponsor:
Jazz Pharmaceuticals
Collaborating Sponsors:
FDA Office of Orphan Products Development
Conditions:
Severe Hepatic Veno-Occlusive Disease
Eligibility:
All Genders
Phase:
PHASE3
Brief 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 endot...
Detailed Description
This is a historically-controlled, multicenter, open label Phase 3 study to determine the safety and efficacy of 25 mg/kg/day of Defibrotide (DF) for the treatment of severe VOD in hematopoietic stem ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2015
Estimated Enrollment :
134 Patients enrolled
Trial Details
Trial ID
NCT00358501
Start Date
July 1 2006
End Date
March 1 2015
Last Update
January 30 2017
Active Locations (25)
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1
Duarte, California, United States
2
Palo Alto, California, United States
3
Denver, Colorado, United States
4
Atlanta, Georgia, United States