Gradual Withdrawal of Immune System Suppressing Drugs in Patients Receiving a Liver Transplant (NCT00135694) | Clinical Trial Compass
CompletedPhase 2
Gradual Withdrawal of Immune System Suppressing Drugs in Patients Receiving a Liver Transplant
United States275 participantsStarted 2005-10
Plain-language 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 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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 criteria
✕. 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.
✕
What they're measuring
1
Number of Participants With Clinical Complications Usually Attributed to Immunosuppression
Timeframe: Randomization to 2 years post-randomization
Trial details
NCT IDNCT00135694
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)