Status:
TERMINATED
Pilot Study of Immunosuppression Drug Weaning in Liver Recipients Exhibiting Biomarkers of High Likelihood of Tolerance
Lead Sponsor:
Hospital Clinic of Barcelona
Conditions:
Liver Transplantation
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
Immunosuppressive drugs can be successfully withdrawn in a fraction of liver transplant patients. Specific peripheral blood gene expression markers can be employed to select patients with a high likel...
Detailed Description
HYPOTHESIS We hypothesize that liver recipients exhibiting either specific gene expression and/or cell phenotypic markers in peripheral blood will be successfully weaned from all immunosuppressive dru...
Eligibility Criteria
Inclusion
- Liver transplant recipients with at least 3 years of post-operative follow-up in whom gene expression pattern changed from non-tolerant to tolerant under sirolimus treatment.
- Feasibility of performing very frequent (every 2-3 weeks) clinical follow-up visits.
- No history of graft rejection during the previous 12 months.
- Basal liver biopsy without signs of rejection
- Stability of liver graft function, defined as: a) normal liver function tests (AST, ALT, ALP, GGT) during at least 6 months; or alternatively b) minor alterations in liver function tests that have not changed over the previous 6 months (AST/ALT \< 2 fold normal levels; ALP \< 1.5 fold normal levels; GGT \< 2 fold normal levels; bilirubin \< 2 mg/dL).
- Presence of peripheral blood biomarkers of high likelihood of tolerance as defined by: a) transcriptional pattern associated with tolerance regardless of the basal immunosuppressive regimen; and/or b) 2-fold increase in Treg frequency in patients who have discontinued calcineurin inhibitors in the 12 months prior to inclusion.
- Signature of informed consent.
Exclusion
- Requirement of immunosuppressive treatment for an indication different to liver transplantation.
- Documented human immunodeficiency virus (HIV) infection.
- Liver-Kidney transplant recipients.
- History of liver autoimmune disease (autoimmune hepatitis, primary liver cirrhosis, primary sclerosing cholangitis)
- Active hepatitis C virus infection as defined by positive serum HCV-RNA.
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2013
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT01445236
Start Date
September 1 2011
End Date
January 1 2013
Last Update
December 20 2013
Active Locations (1)
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1
Hospital Clinic
Barcelona, Barcelona, Spain, 08036