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


Phase 2
18 Years
75 Years
Open (Enrolling)
Both
Liver Transplantation

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

number of participants who have the potential for the operational tolerance

Outcome Description:

measure number of patients who can be weaned off immunosuppression completely

Outcome Time Frame:

in the 2 years fololowing study enrollment

Safety Issue:

Yes

Principal Investigator

Jong Young Choi, Professor

Investigator Role:

Study Chair

Investigator Affiliation:

The Catholic University of Korea

Authority:

Korea: Institutional Review Board

Study ID:

CMCLTIT

NCT ID:

NCT01198314

Start Date:

July 2010

Completion Date:

March 2013

Related Keywords:

  • Liver Transplantation
  • long term
  • stable
  • recipients

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