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

History of Changes

Tracking Information

First Received Date ^ICMJE

September 7, 2010

Last Updated Date

September 9, 2010

Start Date ^ICMJE

July 2010

Estimated Primary Completion Date

July 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01198314 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Withdrawal of Immunosuppression in Long Term Stable Liver Transplant Recipients

Official Title ^ICMJE

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

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.

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 ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

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

Condition ^ICMJE

Liver Transplantation

Intervention ^ICMJE

Procedure: immunosuppression withdrawal
tapering off immunosuppressant

Other Name: WIS
Procedure: continue of taking immunosuppressant
maintain immunosuppression

Other Name: MIS

Study Arm (s)

Experimental: LT, withdrawal of immunosuppression
Intervention: Procedure: immunosuppression withdrawal
Active Comparator: LT, maintenance of immunosuppression
Intervention: Procedure: continue of taking immunosuppressant

Publications *

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. Review.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

March 2013

Estimated Primary Completion Date

July 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 75 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact: Jong Young Choi, Professor

82-2-2258-2073

jychoi@catholic.ac.kr

Location Countries ^ICMJE

Korea, Republic of

Administrative Information

NCT Number ^ICMJE

NCT01198314

Other Study ID Numbers ^ICMJE

CMCLTIT, A092258-0911-1030100

Has Data Monitoring Committee

Yes

Responsible Party

liver transplantation unit, Seoul St. Mary's Hospital

Study Sponsor ^ICMJE

The Catholic University of Korea

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Chair:

Jong Young Choi, Professor

The Catholic University of Korea

Information Provided By

The Catholic University of Korea

Verification Date

July 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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