Gradual Withdrawal of Immune System Suppressing Drugs in Patients Receiving a Liver Transplant
Completed · Phase 2
Conditions studied: Hepatitis C, Hepatitis C, Chronic, Nonimmune Nonviral Causes of Liver Failure
In brief
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 liver. However, these medications can cause long-term side effects, such as infection, kidney problems, diabetes, and cancer. In patients infected with hepatitis C virus (HCV), these medications may increase the risk of HCV infection in the transplanted liver. The purpose of this study is to determine whether a slow withdrawal of immune system-suppressing medications is safe in two groups of subjects: those who receive a liver transplant due to HCV, and those who receive a liver transplant due to non-immune, non-viral causes of liver failure. The study will also look at whether slow withdrawal will help reduce the long-term side effects of immune system-suppressing medications and decrease the chance for HCV infection of the new liver in transplant patients with HCV.
Key facts
- Study ID
- NCT00135694
- Run by
- National Institute of Allergy and Infectious Diseases (NIAID)
- People needed
- 275
- Starts
- 2005-10-01
- Expected to finish
- 2015-09-01
- Last updated by the study team
- 2019-02-04
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- University of California, San Francisco — San Francisco, California, United States
- University of Colorado — Denver, Colorado, United States
- Northwestern University — Chicago, Illinois, United States
- University of Michigan — Ann Arbor, Michigan, United States
- Cleveland Clinic — Cleveland, Ohio, United States
- University of Pennsylvania — Philadelphia, Pennsylvania, United States
- Baylor University — Dallas, Texas, United States
- University of Washington — Seattle, Washington, United States
Full record on ClinicalTrials.gov
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