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

Expanded access is no longer available for this treatment.
(poor enrollment)
Sponsor:
Information provided by (Responsible Party):
John Horan, Emory University
ClinicalTrials.gov Identifier:
NCT00263978
First received: December 9, 2005
Last updated: June 27, 2014
Last verified: June 2014

December 9, 2005
June 27, 2014
November 2005
June 2009   (final data collection date for primary outcome measure)
Not Provided
treatment of veno-occlusive disease
Complete list of historical versions of study NCT00263978 on ClinicalTrials.gov Archive Site
Not Provided
safety of patients
Not Provided
Not Provided
 
Defibrotide Compassionate Use for Patients With Life Threatening Veno-Occlusive Disease of the Liver
Defibrotide Compassionate Use Protocol 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
Not Provided
Not Provided
Liver Diseases
Drug: Defibrotide
Not Provided
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
Not Provided
June 2009
June 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Veno-occlusive disease of the liver
Both
1 Year to 22 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00263978
0966-2005
No
John Horan, Emory University
Emory University
Not Provided
Principal Investigator: John Horan, MD Children's Healthcare of Atlanta
Emory University
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP