Back to resultsDefibrotide Compassionate Use for Patients With Life Threatening Veno-Occlusive Disease of the Liver
Primary Purpose
Liver Diseases
Status
No longer available
Phase
Locations
United States
Study Type
Expanded Access
Intervention
Defibrotide
Sponsored by
About this trial
This is an expanded access trial for Liver Diseases focused on measuring Venous occlusive disease, VOD
Eligibility Criteria
Inclusion Criteria: Veno-occlusive disease of the liver
Sites / Locations
- Children's Healthcare of Atlanta
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00263978
Brief Title
Defibrotide Compassionate Use for Patients With Life Threatening Veno-Occlusive Disease of the Liver
Official Title
Defibrotide Compassionate Use Protocol for Patients With Life Threatening Veno-Occlusive Disease of the Liver
Study Type
Expanded Access
2. Study Status
Record Verification Date
June 2014
Overall Recruitment Status
No longer available
Study Start Date
November 2005 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
June 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Diseases
Keywords
Venous occlusive disease, VOD
7. Study Design
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Defibrotide
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Veno-occlusive disease of the liver
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Horan, MD
Organizational Affiliation
Children's Healthcare of Atlanta
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Healthcare of Atlanta
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Defibrotide Compassionate Use for Patients With Life Threatening Veno-Occlusive Disease of the Liver
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