Clinical trial NCT01198314: Withdrawal of Immunosuppression in Long Term Stable Liver Transplant Recipients
Official title: Gradual Withdrawal of Immunosuppression in Long Term Stable Liver Transplant Recipients Using Immunologic Profile Predicting Operational Tolerance
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Liver Transplantation
Keywords: long term
stable
recipients
Lead sponsor: The Catholic University of Korea
Sponsor class: OTHER
First posted: 2010-09-10
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: number of participants who have the potential for the operational tolerance
timeFrame: in the 2 years fololowing study enrollment
Secondary outcomes:
measure: Tolerance biomarker
timeFrame: 1 year following immunosuppression withdrawal
measure: immunologic profile related to rejection
timeFrame: up to 2 years following withdrawal of immunosuppression
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul St. Mary's Hospital
Study officials:
affiliation: The Catholic University of Korea
name: Jong Young Choi, Professor
role: STUDY_CHAIR
References:
citation: Castellaneta A, Thomson AW, Nayyar N, de Vera M, Mazariegos GV. Monitoring the operationally tolerant liver allograft recipient. Curr Opin Organ Transplant. 2010 Feb;15(1):28-34. doi: 10.1097/MOT.0b013e328334269a.