At a glance
ClinicalIndex Comparison Record- ✓Age 18 years or older
- ✓Candidate for liver transplant with available donor specimen
- ✓For hepatitis C patients: presence of hepatitis C genome in blood
- ✓Females of childbearing potential must have negative pregnancy test and use approved birth control
- ✕Previous solid organ transplant
- ✕Multiorgan or split liver transplant (except right trisegment)
- ✕Living donor transplant
- ✕Donor positive for hepatitis C antibody or non-heart-beating donor
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase II Trial to Assess the Safety of Immunosuppression Withdrawal in Liver Transplant Recipients
In Brief
A Phase 2 clinical trial evaluating calcineurin inhibitor-based immunosuppression, liver transplant, and 2 other interventions for Hepatitis C and 2 related conditions. Completed, enrolled 275 participants across 8 sites.
Detailed 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.
Study Details
Timeline
Interventions
May be cyclosporine, mycophenolate mofetil, or tacrolimus
Occurs at study entry
3-month course of corticosteroids
One year after transplantation, participants eligible for withdrawal are randomly assigned in a 4 to 1 ratio to immunosuppression withdrawal or to maintenance.