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

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ClinicalTrials.gov Identifier: NCT01198314
Recruitment Status : Unknown
Verified July 2010 by The Catholic University of Korea.
Recruitment status was:  Recruiting
First Posted : September 10, 2010
Last Update Posted : September 10, 2010
Sponsor:
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment Phase
Liver Transplantation Procedure: immunosuppression withdrawal Procedure: continue of taking immunosuppressant Phase 2

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Gradual Withdrawal of Immunosuppression in Long Term Stable Liver Transplant Recipients Using Immunologic Profile Predicting Operational Tolerance
Study Start Date : July 2010
Estimated Primary Completion Date : July 2012
Estimated Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Tolerance biomarker [ Time Frame: 1 year following immunosuppression withdrawal ]
    find out biomarkers which can predict operational tolerance

  2. immunologic profile related to rejection [ Time Frame: up to 2 years following withdrawal of immunosuppression ]
    observe immunologic profile changes which are related to rejection


Eligibility Criteria

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 ( Other Grant/Funding Number: A092258-0911-1030100 )
First Posted: September 10, 2010    Key Record Dates
Last Update Posted: September 10, 2010
Last Verified: July 2010

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

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