Withdrawal of Immunosuppression in Long Term Stable Liver Transplant Recipients (tolerance)
Recruitment status was: Recruiting
|Liver Transplantation||Procedure: immunosuppression withdrawal Procedure: continue of taking immunosuppressant||Phase 2|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Gradual Withdrawal of Immunosuppression in Long Term Stable Liver Transplant Recipients Using Immunologic Profile Predicting Operational Tolerance|
- number of participants who have the potential for the operational tolerance [ Time Frame: in the 2 years fololowing study enrollment ]measure number of patients who can be weaned off immunosuppression completely
- Tolerance biomarker [ Time Frame: 1 year following immunosuppression withdrawal ]find out biomarkers which can predict operational tolerance
- immunologic profile related to rejection [ Time Frame: up to 2 years following withdrawal of immunosuppression ]observe immunologic profile changes which are related to rejection
|Study Start Date:||July 2010|
|Estimated Study Completion Date:||March 2013|
|Estimated Primary Completion Date:||July 2012 (Final data collection date for primary outcome measure)|
|Experimental: LT, withdrawal of immunosuppression||
Procedure: immunosuppression withdrawal
tapering off immunosuppressant
Other Name: WIS
|Active Comparator: LT, maintenance of immunosuppression||
Procedure: continue of taking immunosuppressant
Other Name: MIS
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01198314
|Contact: Jong Young Choi, Professoremail@example.com|
|Korea, Republic of|
|Seoul St. Mary's Hospital||Recruiting|
|Seoul, Korea, Republic of, 137-040|
|Contact: Jong Young Choi, Professor 82-2-2258-2073 firstname.lastname@example.org|
|Study Chair:||Jong Young Choi, Professor||The Catholic University of Korea|