Withdrawal of Immunosuppression in Long Term Stable Liver Transplant Recipients

Liver Transplantation Clinical Trial

— tolerance  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01198314
• Other study ID #: CMCLTIT
• Secondary ID: A092258-0911-103
• Status: Recruiting
• Phase: Phase 2
• First received: September 7, 2010
• Last updated: September 9, 2010
• Start date: July 2010
• Est. completion date: March 2013

Study information

• Verified date: July 2010
• Source: The Catholic University of Korea
• Contact: Jong Young Choi, Professor
• Phone: 82-2-2258-2073
• Email: jychoi[@]catholic.ac.kr
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: March 2013
• Est. primary completion date: July 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Liver Transplantation

Intervention

Procedure:
• immunosuppression withdrawal
tapering off immunosuppressant
• continue of taking immunosuppressant
maintain immunosuppression

Locations

Country	Name	City	State
Korea, Republic of	Seoul St. Mary's Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
The Catholic University of Korea

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (1)

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of participants who have the potential for the operational tolerance	measure number of patients who can be weaned off immunosuppression completely	in the 2 years fololowing study enrollment	Yes
Secondary	Tolerance biomarker	find out biomarkers which can predict operational tolerance	1 year following immunosuppression withdrawal	No
Secondary	immunologic profile related to rejection	observe immunologic profile changes which are related to rejection	up to 2 years following withdrawal of immunosuppression	No