Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

September 7, 2010
September 9, 2010
July 2010
July 2012   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01198314 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Withdrawal of Immunosuppression in Long Term Stable Liver Transplant Recipients
Gradual Withdrawal of Immunosuppression in Long Term Stable Liver Transplant Recipients Using Immunologic Profile Predicting Operational Tolerance

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.

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.

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Liver Transplantation
  • Procedure: immunosuppression withdrawal
    tapering off immunosuppressant
    Other Name: WIS
  • Procedure: continue of taking immunosuppressant
    maintain immunosuppression
    Other Name: MIS
  • Experimental: LT, withdrawal of immunosuppression
    Intervention: Procedure: immunosuppression withdrawal
  • Active Comparator: LT, maintenance of immunosuppression
    Intervention: Procedure: continue of taking immunosuppressant
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.
 
Recruiting
20
March 2013
July 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
Yes
Contact: Jong Young Choi, Professor 82-2-2258-2073 jychoi@catholic.ac.kr
Korea, Republic of
 
NCT01198314
CMCLTIT, A092258-0911-1030100
Yes
liver transplantation unit, Seoul St. Mary's Hospital
The Catholic University of Korea
Not Provided
Study Chair: Jong Young Choi, Professor The Catholic University of Korea
The Catholic University of Korea
July 2010

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