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

September 9, 2010 updated by: The Catholic University of Korea

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: LT, withdrawal of immunosuppression
Procedure: immunosuppression withdrawal
tapering off immunosuppressant
Other Names:
  • WIS
ACTIVE_COMPARATOR: LT, maintenance of immunosuppression
Procedure: continue of taking immunosuppressant
maintain immunosuppression
Other Names:
  • MIS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
in the 2 years fololowing study enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tolerance biomarker
Time Frame: 1 year following immunosuppression withdrawal
find out biomarkers which can predict operational tolerance
1 year following immunosuppression withdrawal
immunologic profile related to rejection
Time Frame: up to 2 years following withdrawal of immunosuppression
observe immunologic profile changes which are related to rejection
up to 2 years following withdrawal of immunosuppression

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Catholic University of Korea

Investigators

  • Study Chair: Jong Young Choi, Professor, The Catholic University of Korea

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2010

Primary Completion (ANTICIPATED)

July 1, 2012

Study Completion (ANTICIPATED)

March 1, 2013

Study Registration Dates

First Submitted

September 7, 2010

First Submitted That Met QC Criteria

September 9, 2010

First Posted (ESTIMATE)

September 10, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

September 10, 2010

Last Update Submitted That Met QC Criteria

September 9, 2010

Last Verified

July 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CMCLTIT
  • A092258-0911-1030100 (OTHER_GRANT: A092258-0911-1030100)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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