Long-term immunosuppression carries potential adverse effects such as risk of infection, malignancy, renal insufficiency, diabetes and hypertension. In clinical liver transplantation, some liver transplant recipients maintain allograft function without immunosuppressive drugs. This is called as "operational tolerance". Many attempts have been made to identify immunological biomarkers predicting operational tolerant patients. Therefore, the investigators aimed to identify patients who have the potential to be operationally tolerant using biomarkers, withdraw immunosuppressant gradually and stop ultimately with monitoring of biomarkers.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
tapering off immunosuppressant
maintain immunosuppression
Seoul St. Mary's Hospital
Seoul, South Korea
RECRUITINGnumber of participants who have the potential for the operational tolerance
measure number of patients who can be weaned off immunosuppression completely
Time frame: in the 2 years fololowing study enrollment
Tolerance biomarker
find out biomarkers which can predict operational tolerance
Time frame: 1 year following immunosuppression withdrawal
immunologic profile related to rejection
observe immunologic profile changes which are related to rejection
Time frame: up to 2 years following withdrawal of immunosuppression
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