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Compassionate Use of Defibrotide for Patients With Veno-occlusive Disease of the Liver

Sponsor
St. Jude Children's Research Hospital (Other)
Overall Status
No longer available
CT.gov ID
NCT00143546
Collaborator
(none)
1
Location

Study Details

Study Description

Brief Summary

Veno-occlusive disease (VOD) of the liver is a significant complication for some patients undergoing hematopoietic stem cell transplantation. This disease is thought to be a toxicity secondary to chemotherapy or radiation-induced damage to the epithelial cells of the blood vessels in the liver. VOD is categorized as mild, moderate or severe. Historically, there has been no method to treat the disease. Recently, however, there have been investigations into the use of a new agent called defibrotide.

The primary purpose of this protocol is to provide defibrotide to patients with severe VOD. Because this drug has not been approved by the FDA, use of this medication under the auspices of this IND treatment plan is for compassionate use only.

Condition or Disease Intervention/Treatment Phase

Detailed Description

Secondary objectives of this protocol include the following:

  • To describe the toxicities of defibrotide in patients with VOD.

  • To describe the response rate of VOD in patients receiving defibrotide.

Study Design

Study Type:
Expanded Access
Official Title:
Compassionate Use of Defibrotide for Patients With Veno-Occlusive Disease
Study Start Date :
Nov 1, 2003

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    Patients with clinical or pathologic diagnosis of veno-occlusive disease. The following criteria will be used:

    1. Hyperbilirubinemia (greater than or equal to 2mg/dl) and two of the following: (hepatomegaly, ascites, or weight gain [greater than or equal to 5% of baseline]); OR,

    2. Patient who do not fulfill criteria in #1 but who have pathologic or radiographic evidence of VOD.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 St. Jude Children's Research Hospital Memphis Tennessee United States 38105

    Sponsors and Collaborators

    • St. Jude Children's Research Hospital

    Investigators

    • Principal Investigator: Wing Leung, M.D., St. Jude Children's Research Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    St. Jude Children's Research Hospital
    ClinicalTrials.gov Identifier:
    NCT00143546
    Other Study ID Numbers:
    • DETIDE
    First Posted:
    Sep 2, 2005
    Last Update Posted:
    Apr 25, 2017
    Last Verified:
    Apr 1, 2017
    Keywords provided by St. Jude Children's Research Hospital
    Hepatic Veno-occlusive Disease
    Additional relevant MeSH terms:
    Hepatic Veno-Occlusive Disease
    Defibrotide

    Study Results

    No Results Posted as of Apr 25, 2017