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

Sponsor
Emory University (Other)
Overall Status
No longer available
CT.gov ID
NCT00263978
Collaborator
(none)
1
Location
43
Duration (Months)

Study Details

Study Description

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 Phase

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 Design

Study Type:
Expanded Access
Official Title:
Defibrotide Compassionate Use Protocol for Patients With Life Threatening Veno-Occlusive Disease of the Liver
Study Start Date :
Nov 1, 2005
Actual Primary Completion Date :
Jun 1, 2009
Actual Study Completion Date :
Jun 1, 2009

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    1 Year to 22 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Veno-occlusive disease of the liver

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    John Horan, Principal Investigator, Emory University
    ClinicalTrials.gov Identifier:
    NCT00263978
    Other Study ID Numbers:
    • 0966-2005
    First Posted:
    Dec 12, 2005
    Last Update Posted:
    Jul 1, 2014
    Last Verified:
    Jun 1, 2014
    Keywords provided by John Horan, Principal Investigator, Emory University
    Venous occlusive disease
    VOD
    Additional relevant MeSH terms:
    Liver Diseases
    Hepatic Veno-Occlusive Disease
    Defibrotide

    Study Results

    No Results Posted as of Jul 1, 2014