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Withdrawal of Immunosuppression in Long Term Stable Liver Transplant Recipients — tolerance  

Liver Transplantation Clinical Trial

Official title:
Gradual Withdrawal of Immunosuppression in Long Term Stable Liver Transplant Recipients Using Immunologic Profile Predicting Operational Tolerance

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01198314
Study type Interventional
Source The Catholic University of Korea
Contact Jong Young Choi, Professor
Phone 82-2-2258-2073
Email jychoi@catholic.ac.kr
Status Recruiting
Phase Phase 2
Start date July 2010
Completion date March 2013
View Details
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