Status:
COMPLETED
Withdrawal of Immunosuppression in Pediatric Liver Transplant Recipients
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsors:
Immune Tolerance Network (ITN)
Conditions:
Liver Transplant
Liver Transplantation
Eligibility:
All Genders
4-18 years
Phase:
PHASE1
Brief Summary
Antirejection medicines, also known as immunosuppressive drugs, are prescribed to organ transplant recipients to prevent their bodies from rejecting the new organ. Long-term use of these drugs places ...
Detailed Description
In order to prevent the rejection of transplanted organs, transplant recipients are prescribed a strict, lifelong regimen of immunosuppressive drugs. While these drugs help prevent the body from rejec...
Eligibility Criteria
Inclusion
- Inclusion Criteria for Liver Recipients:
- Received liver from living parent donor
- Received transplant at least 4 years prior to study entry
- Less than 18 years of age at time of transplant
- Parent or guardian willing to provide informed consent
- Inclusion Criteria for Liver Donors:
- Willing to participate in this study
- Exclusion Criteria for Liver Recipients:
- Underwent transplant because of liver failure related to autoimmune disease
- Underwent transplant of a second organ simultaneously with or after liver transplant OR liver retransplantation
- Receiving immunosuppression with more than one drug
- 50% increase in dose of current immunosuppressive drug
- HIV infection
- Hepatitis B or C virus infection
- Pregnancy or breastfeeding
Exclusion
Key Trial Info
Start Date :
June 5 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 13 2017
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00320606
Start Date
June 5 2006
End Date
March 13 2017
Last Update
September 20 2018
Active Locations (3)
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1
University of California, San Francisco
San Francisco, California, United States, 94143
2
Children's Memorial Hospital
Chicago, Illinois, United States, 60614
3
Columbia University Medical Center
New York, New York, United States, 10032