Trial Information

Summary: Defibrotide for the Treatment of Severe Hepatic Veno-Occlusive Disease in Hematopoietic Stem Cell Transplant Patients: A Historically-Controlled, Multi-Center Phase III Study to Determine Safety and Efficacy

You have/your child has been asked to participate in this research study because you have/your child has severe hepatic (related to the liver) veno-occlusive disease (VOD) following a hematopoietic stem cell transplant (HSCT) of bone marrow and/or blood stem cells.  The purpose of this study is to evaluate the effectiveness and safety of the investigational drug Defibrotide in the treatment of severe hepatic VOD.  Another purpose is to collect blood specimens for laboratory studies on VOD. Your/your child’s participation in this study is expected to last at least 21 days for treatment.  You/your child may receive the study drug longer if the study doctor thinks you/your child may benefit.  After your/your child’s treatment on this study has been completed, your/your child’s medical condition will be followed for about 6 months for follow-up.

Patient Inclusion/Exclusion Criteria:

- See http://clinicaltrials.coh.org for additional information.

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Trial listings updated: June 2, 2008 at 2:50:57 PM