Status:
COMPLETED
Effect of Immunosuppression Drug Weaning on Hepatitis C Virus (HCV)-Induced Liver Damage After Liver Transplantation
Lead Sponsor:
Hospital Clinic of Barcelona
Conditions:
Hepatitis C Virus Infection
Liver Transplantation
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
Viral infections can profoundly influence alloimmune responses and hamper allograft tolerance induction. Persistent hepatitis C virus (HCV) infection occurs in 50% of liver and 20% of kidney transplan...
Detailed Description
Objective: To determine the influence of hepatitis C virus (HCV)-driven immune responses on the acquisition of operational tolerance in liver transplant recipients following drug weaning, and to asses...
Eligibility Criteria
Inclusion
- Liver transplantation for HCV-related liver disease performed at least 3 years before weaning;
- Peripheral blood Vgd1+/Vgd2+ T cell ratio \>2.33 and/or increased expression of KLRF1 and SLAMF7 genes in peripheral blood (measured by qPCR).
- No indication for treatment with pegylated a-interferon plus ribavirin during the weaning procedure;
- Stability of liver function tests for at least 6 months;
- No evidences of autoimmune liver disease;
- Absence of acute and/or chronic rejection episodes during the 12 months before weaning;
- Basal liver biopsy without signs of acute and/or chronic rejection.
- Absence of decompensated chronic liver disease.
Exclusion
- HIV infection
- Double liver-kidney transplantation
- HCV cholestatic fibrosing hepatitis
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT00668369
Start Date
April 1 2008
End Date
September 1 2011
Last Update
December 20 2013
Active Locations (1)
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1
Hospital Clinic Barcelona, University of Barcelona
Barcelona, Spain, 08036