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

This study has been terminated.
(poor enrollment)
Sponsor:
Information provided by (Responsible Party):
John Horan, Emory University
ClinicalTrials.gov Identifier:
NCT00263978
First received: December 9, 2005
Last updated: November 26, 2013
Last verified: November 2013

December 9, 2005
November 26, 2013
November 2005
June 2009   (final data collection date for primary outcome measure)
treatment of veno-occlusive disease [ Time Frame: enrollment ] [ Designated as safety issue: No ]
treatment of veno-occlusive disease
Complete list of historical versions of study NCT00263978 on ClinicalTrials.gov Archive Site
safety of patients [ Time Frame: enrollment ] [ Designated as safety issue: No ]
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.

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Liver Diseases
Drug: Defibrotide
single arm
compassionate use study
Intervention: Drug: Defibrotide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
2
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
November 2013

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