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

Liver Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: No longer available

Administrative data

• NCT number: NCT00263978
• Other study ID #: 0966-2005
• Status: No longer available
• Phase: N/A
• First received: December 9, 2005
• Last updated: June 27, 2014
• Start date: November 2005
• Est. completion date: June 2009

Study information

• Verified date: June 2014
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Expanded Access

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: No longer available
• Enrollment: 0
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 22 Years

Eligibility

Inclusion Criteria:

• Veno-occlusive disease of the liver

Study Design

N/A

Related Conditions & MeSH terms

• Hepatic Veno-Occlusive Disease
• Liver Diseases

Intervention

Drug:
• Defibrotide

Locations

Country	Name	City	State
United States	Children's Healthcare of Atlanta	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Emory University

Country where clinical trial is conducted

United States,