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Withdrawal of Immunosuppression in Long Term Stable Liver Transplant Recipients

NCT ID: NCT01198314

Last Updated: 2010-09-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2013-03-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Liver Transplantation

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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LT, withdrawal of immunosuppression

Group Type EXPERIMENTAL

immunosuppression withdrawal

Intervention Type PROCEDURE

tapering off immunosuppressant

LT, maintenance of immunosuppression

Group Type ACTIVE_COMPARATOR

continue of taking immunosuppressant

Intervention Type PROCEDURE

maintain immunosuppression

Interventions

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immunosuppression withdrawal

tapering off immunosuppressant

Intervention Type PROCEDURE

continue of taking immunosuppressant

maintain immunosuppression

Intervention Type PROCEDURE

Other Intervention Names

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WIS MIS

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The Catholic University of Korea

OTHER

Sponsor Role lead

Responsible Party

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Seoul St. Mary's Hospital

Principal Investigators

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Jong Young Choi, Professor

Role: STUDY_CHAIR

The Catholic University of Korea

Locations

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Seoul St. Mary's Hospital

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Jong Young Choi, Professor

Role: CONTACT

[email protected]
82-2-2258-2073

Facility Contacts

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Jong Young Choi, Professor

Role: primary

[email protected]
82-2-2258-2073

References

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Castellaneta A, Thomson AW, Nayyar N, de Vera M, Mazariegos GV. Monitoring the operationally tolerant liver allograft recipient. Curr Opin Organ Transplant. 2010 Feb;15(1):28-34. doi: 10.1097/MOT.0b013e328334269a.

Reference Type BACKGROUND
PMID: 19890211 (View on PubMed)

Other Identifiers

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A092258-0911-1030100

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

CMCLTIT

Identifier Type: -

Identifier Source: org_study_id