Status:
COMPLETED
Gradual Withdrawal of Immune System Suppressing Drugs in Patients Receiving a Liver Transplant
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsors:
Immune Tolerance Network (ITN)
Conditions:
Hepatitis C
Hepatitis C, Chronic
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
In order to prevent organ rejection, patients receiving liver transplants currently require life-long treatment with immune system-suppressing medications to prevent the rejection of the transplanted ...
Detailed Description
This is a prospective multicenter, open-label, randomized trial in which individuals with liver failure due to hepatitis C or to nonimmune nonviral causes undergo liver transplantation and receive imm...
Eligibility Criteria
Inclusion
- Male or female 18 years of age or older.
- Necessity for liver transplant.
- For females of childbearing potential: a negative pregnancy test at study entry and agreement to use approved methods of birth control for the duration of their participation.
- Ability to provide informed consent.
- Availability of donor specimen(s).
- For individuals with hepatitis C infection, presence of hepatitis genomes in blood.
Exclusion
- Previous transplant.
- Multiorgan or split liver transplant other than with a right trisegment.
- Living donor transplant.
- Donor liver from a donor positive for antibody against hepatitis C.
- Donor liver from a non-heart-beating donor.
- Liver failure due to autoimmune disease.
- Fulminant liver failure.
- Hepatitis B infection as defined by the presence of HbSAg or hepatitis-C infection with a genome other than genome 1.
- Stage III or higher hepatocellular cancer.
- History of malignancy except hepatocellular cancer, adequately treated in situ cervical carcinoma,adequately treated basal or squamous cell carcinoma of skin, or other cancer judged to have a 5-year risk of recurrence less than 10%.
- Active systemic infection at the time of transplantation.
- Clinically significant chronic renal disease.
- Clinically significant cardiovascular or cerebrovascular disease.
- Infection with human immunodeficiency virus.
- Any investigational drug received within 6 weeks of study entry or any investigational vaccine received at any time.
- Hypersensitivity to tacrolimus.
- Unwillingness or inability to comply with study requirements.
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2015
Estimated Enrollment :
275 Patients enrolled
Trial Details
Trial ID
NCT00135694
Start Date
October 1 2005
End Date
September 1 2015
Last Update
February 4 2019
Active Locations (8)
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1
University of California, San Francisco
San Francisco, California, United States, 94143
2
University of Colorado
Denver, Colorado, United States, 80262
3
Northwestern University
Chicago, Illinois, United States, 60208
4
University of Michigan
Ann Arbor, Michigan, United States, 48109