Clinical Trial: Defibrotide Compassionate Use for Patients With Life Threatening Veno-Occlusive Disease of the Liver

Study Status: No longer available
Recruit Status: No longer available
Study Type: Expanded Access

Official Title: Defibrotide Compassionate Use Protocol for Patients With Life Threatening Veno-Occlusive Disease of the Liver

Brief Summary: Severe veno-occlusive disease (VOD) of the liver is a life threatening complication of blood and marrow transplantation. Treatment with currently available (Food and Drug Administration [FDA] approved) agents fails in most cases. Recently conducted clinical studies indicate that patients benefit from defibrotide, a non-FDA approved agent. This protocol has been developed not with a research intent, but rather to ensure that defibrotide is used by the blood and marrow transplant programs at Children's Healthcare of Atlanta and at Emory University in a safe, effective and ethical manner.

Detailed Summary: Severe veno-occlusive disease (VOD) of the liver is a life threatening complication of blood and marrow transplantation. Treatment with currently available (FDA approved) agents fails in most cases. Recently conducted clinical studies indicate that patients benefit from defibrotide, a non-FDA approved agent. This protocol has been developed not with a research intent, but rather to ensure that defibrotide is used by the blood and marrow transplant programs at Children's Healthcare of Atlanta and at Emory University in a safe, effective and ethical manner.
Sponsor: Emory University

Current Primary Outcome:

Original Primary Outcome: treatment of veno-occlusive disease

Current Secondary Outcome:

Original Secondary Outcome: safety of patients

Information By: Emory University

Dates:
Date Received: December 9, 2005
Date Started: November 2005
Date Completion:
Last Updated: June 27, 2014
Last Verified: June 2014