Status:

NO_LONGER_AVAILABLE

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

Lead Sponsor:

St. Jude Children's Research Hospital

Conditions:

Hepatic Veno-occlusive Disease

Eligibility:

All Genders

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 chem...

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...

Eligibility Criteria

Inclusion

  • Inclusion Criteria:
  • Patients with clinical or pathologic diagnosis of veno-occlusive disease. The following criteria will be used:
  • 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,
  • Patient who do not fulfill criteria in #1 but who have pathologic or radiographic evidence of VOD.

Exclusion

    Key Trial Info

    Start Date :

    November 1 2003

    Trial Type :

    EXPANDED_ACCESS

    End Date :

    Estimated Enrollment :

    Patients enrolled

    Trial Details

    Trial ID

    NCT00143546

    Start Date

    November 1 2003

    Last Update

    April 25 2017

    Active Locations (1)

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    1

    St. Jude Children's Research Hospital

    Memphis, Tennessee, United States, 38105