Defibrotide for the Treatment of Severe Hepatic Veno-Occlusive Disease in Hematopoetic Stem Cell Transplant Patients

Completed · Phase 3

Conditions studied: Severe Hepatic Veno-Occlusive Disease

In brief

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.

Key facts

Study ID

NCT00358501

Run by

Jazz Pharmaceuticals

People needed

134

Starts

2006-07-01

Expected to finish

2015-03-01

Last updated by the study team

2017-01-30

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Study site — Duarte, California, United States
• Study site — Palo Alto, California, United States
• Study site — Denver, Colorado, United States
• Study site — Atlanta, Georgia, United States
• Study site — Chicago, Illinois, United States
• Study site — Maywood, Illinois, United States
• Study site — Indianapolis, Indiana, United States
• Study site — Baltimore, Maryland, United States
• Study site — Boston, Massachusetts, United States
• Study site — Ann Arbor, Michigan, United States
• Study site — Minneapolis, Minnesota, United States
• Study site — Rochester, Minnesota, United States
• Study site — St Louis, Missouri, United States
• Study site — Omaha, Nebraska, United States
• Study site — Hackensack, New Jersey, United States
• Study site — New York, New York, United States
• Study site — Durham, North Carolina, United States
• Study site — Columbus, Ohio, United States
• Study site — Portland, Oregon, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Houston, Texas, United States
• Study site — Seattle, Washington, United States
• Study site — Vancouver, British Columbia, Canada
• Study site — Toronto, Ontario, Canada
• Study site — Montreal, Quebec, Canada

Full record on ClinicalTrials.gov

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