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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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

Brief 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.

Condition or disease Intervention/treatment
Liver Diseases Drug: Defibrotide

Detailed 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 Type : Expanded Access
Official Title: Defibrotide Compassionate Use Protocol for Patients With Life Threatening Veno-Occlusive Disease of the Liver
Study Start Date : November 2005
Primary Completion Date : June 2009
Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Liver Diseases
U.S. FDA Resources



Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 22 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Veno-occlusive disease of the liver

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00263978


Locations
United States, Georgia
Children's Healthcare of Atlanta
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
Investigators
Principal Investigator: John Horan, MD Children's Healthcare of Atlanta

Responsible Party: John Horan, Principal Investigator, Emory University
ClinicalTrials.gov Identifier: NCT00263978     History of Changes
Other Study ID Numbers: 0966-2005
First Posted: December 12, 2005    Key Record Dates
Last Update Posted: July 1, 2014
Last Verified: June 2014

Keywords provided by John Horan, Emory University:
Venous occlusive disease
VOD

Additional relevant MeSH terms:
Liver Diseases
Hepatic Veno-Occlusive Disease
Digestive System Diseases
Vascular Diseases
Cardiovascular Diseases
Defibrotide
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors