Withdrawal of Immunosuppression in Long Term Stable Liver Transplant Recipients

Phase 2

• Conditions: Liver Transplantation
• Interventions: Procedure: immunosuppression withdrawal; Procedure: continue of taking immunosuppressant

• Registration Number: NCT01198314
• Lead Sponsor: The Catholic University of Korea

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.

Study Timeline

• Status Verified: 2010-07
• Study Start: 2010-07
• Study First Submitted: 2010-09-07
• Study First Submitted QC: 2010-09-09
• Last Update Submitted: 2010-09-09
• Study First Posted: 2010-09-10
• Last Update Posted: 2010-09-10
• Primary Completion: 2012-07
• Study Completion: 2013-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
LT, withdrawal of immunosuppression	immunosuppression withdrawal	-
LT, maintenance of immunosuppression	continue of taking immunosuppressant	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Seoul St. Mary's Hospital; 🇰🇷 Seoul, Korea, Republic of