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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):
John Horan, Emory University

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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
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