Withdrawal of Immunosuppression in Long Term Stable Liver Transplant Recipients (tolerance)

The Catholic University of Korea

Status and phase: Unknown; Phase 2

Conditions: Liver Transplantation

Treatments: Procedure: continue of taking immunosuppressant; Procedure: immunosuppression withdrawal

Study type: Interventional

Funder types: Other

Identifiers

NCT01198314

CMCLTIT

A092258-0911-1030100 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

LT, withdrawal of immunosuppression

Experimental group

Treatment:

Procedure: immunosuppression withdrawal

LT, maintenance of immunosuppression

Active Comparator group

Treatment:

Procedure: continue of taking immunosuppressant