Liver Transplantation
Conditions
Keywords
long term, stable, recipients
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREimmunosuppression withdrawal
tapering off immunosuppressant
PROCEDUREcontinue of taking immunosuppressant
maintain immunosuppression
Sponsors
The Catholic University of Korea
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* long term stable liver transplant recipients
Exclusion criteria
* liver transplant due to autoimmune disease * liver transplant due to hepatitis C virus (HCV) * history of graft rejection * history of biliary infection or stricture
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| number of participants who have the potential for the operational tolerance | in the 2 years fololowing study enrollment | measure number of patients who can be weaned off immunosuppression completely |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tolerance biomarker | 1 year following immunosuppression withdrawal | find out biomarkers which can predict operational tolerance |
| immunologic profile related to rejection | up to 2 years following withdrawal of immunosuppression | observe immunologic profile changes which are related to rejection |
Countries
South Korea
Contacts
Primary ContactJong Young Choi, Professor
Outcome results
None listed