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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by The Catholic University of Korea.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
The Catholic University of Korea
ClinicalTrials.gov Identifier:
NCT01198314
First received: September 7, 2010
Last updated: September 9, 2010
Last verified: July 2010
  Purpose

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.


Condition Intervention Phase
Liver Transplantation
Procedure: immunosuppression withdrawal
Procedure: continue of taking immunosuppressant
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
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

Resource links provided by NLM:


Further study details as provided by The Catholic University of Korea:

Primary Outcome Measures:
  • number of participants who have the potential for the operational tolerance [ Time Frame: in the 2 years fololowing study enrollment ] [ Designated as safety issue: Yes ]
    measure number of patients who can be weaned off immunosuppression completely


Secondary Outcome Measures:
  • Tolerance biomarker [ Time Frame: 1 year following immunosuppression withdrawal ] [ Designated as safety issue: No ]
    find out biomarkers which can predict operational tolerance

  • immunologic profile related to rejection [ Time Frame: up to 2 years following withdrawal of immunosuppression ] [ Designated as safety issue: No ]
    observe immunologic profile changes which are related to rejection


Estimated Enrollment: 20
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)
Arms Assigned Interventions
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
maintain immunosuppression
Other Name: MIS

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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01198314

Contacts
Contact: Jong Young Choi, Professor 82-2-2258-2073 jychoi@catholic.ac.kr

Locations
Korea, Republic of
Seoul St. Mary's Hospital Recruiting
Seoul, Korea, Republic of, 137-040
Contact: Jong Young Choi, Professor    82-2-2258-2073    jychoi@catholic.ac.kr   
Sponsors and Collaborators
The Catholic University of Korea
Investigators
Study Chair: Jong Young Choi, Professor The Catholic University of Korea
  More Information

Publications:
Responsible Party: liver transplantation unit, Seoul St. Mary's Hospital
ClinicalTrials.gov Identifier: NCT01198314     History of Changes
Other Study ID Numbers: CMCLTIT, A092258-0911-1030100
Study First Received: September 7, 2010
Last Updated: September 9, 2010
Health Authority: Korea: Institutional Review Board

Keywords provided by The Catholic University of Korea:
long term
stable
recipients

Additional relevant MeSH terms:
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 28, 2014