Gradual Withdrawal of Immunosuppression in Long Term Stable Liver Transplant Recipients Using Immunologic Profile Predicting Operational Tolerance
Among long term stable liver transplant recipients, we will select some proportion of
patients who have the high potential for obtaining operational tolerance using biomarkers.
Then, we will gradually reduce immunosuppressants and monitor biomarkers as well as
biochemical tests. The course of tapering off immunosuppressant will take about 1 year.
During withdrawal of immunosuppression, participants will be closely monitored for liver
enzyme, immunological profile.
If there are some signs of rejection, liver biopsy will be undertaken and participants will
be treated using immunosuppressant.
After complete withdrawal of immunosuppressant, participants will be followed for at least
of 1 year.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
number of participants who have the potential for the operational tolerance
measure number of patients who can be weaned off immunosuppression completely
in the 2 years fololowing study enrollment
Jong Young Choi, Professor
The Catholic University of Korea
Korea: Institutional Review Board