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

NCT00263978 · Status: NO_LONGER_AVAILABLE · Type: EXPANDED_ACCESS

Last updated 2014-07-01

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Defibrotide

Sponsors & Collaborators

  • Emory University

    lead OTHER

Principal Investigators

  • John Horan, MD · Children's Healthcare of Atlanta

Eligibility

Min Age
1 Year
Max Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-11-30
Primary Completion
2009-06-30
Completion
2009-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00263978 on ClinicalTrials.gov