Withdrawal of Immunosuppression in Long Term Stable Liver Transplant Recipients
tolerance
Gradual Withdrawal of Immunosuppression in Long Term Stable Liver Transplant Recipients Using Immunologic Profile Predicting Operational Tolerance
2 other identifiers
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Jul 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2010
CompletedFirst Submitted
Initial submission to the registry
September 7, 2010
CompletedFirst Posted
Study publicly available on registry
September 10, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2013
CompletedSeptember 10, 2010
July 1, 2010
2 years
September 7, 2010
September 9, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (2)
Tolerance biomarker
1 year following immunosuppression withdrawal
immunologic profile related to rejection
up to 2 years following withdrawal of immunosuppression
Study Arms (2)
LT, withdrawal of immunosuppression
EXPERIMENTALLT, maintenance of immunosuppression
ACTIVE COMPARATORInterventions
tapering off immunosuppressant
maintain immunosuppression
Eligibility Criteria
You may qualify if:
- long term stable liver transplant recipients
You may not qualify if:
- liver transplant due to autoimmune disease
- liver transplant due to hepatitis C virus (HCV)
- history of graft rejection
- history of biliary infection or stricture
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul St. Mary's Hospital
Seoul, 137-040, South Korea
Related 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.
PMID: 19890211BACKGROUND
Study Officials
- STUDY CHAIR
Jong Young Choi, Professor
The Catholic University of Korea
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 7, 2010
First Posted
September 10, 2010
Study Start
July 1, 2010
Primary Completion
July 1, 2012
Study Completion
March 1, 2013
Last Updated
September 10, 2010
Record last verified: 2010-07