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

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ClinicalTrials.gov Identifier: NCT00263978
Recruitment Status : No longer available (poor enrollment)
First Posted : December 12, 2005
Last Update Posted : July 1, 2014
Sponsor:
Information provided by (Responsible Party):

December 9, 2005
December 12, 2005
July 1, 2014
 
Defibrotide Compassionate Use for Patients With Life Threatening Veno-Occlusive Disease of the Liver
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.
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.
Expanded Access
Drug: Defibrotide
Not Provided
 
No longer available
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00263978
John Horan, Emory University
Emory University
Not Provided
Principal Investigator: John Horan, MD Children's Healthcare of Atlanta
Emory University
June 2014