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

Liver Diseases Clinical Trial

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

Clinical Trial 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.

Clinical Trial Description

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. ;

Study Design

N/A

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00263978
Study type Expanded Access
Source Emory University
Contact
Status No longer available
Phase N/A
Start date November 2005
Completion date June 2009
View Details
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