Status:
UNKNOWN
Assessment Of the Safety and Benefit of Prospective Immunosuppressive Drug Withdrawal in Liver Transplantation and Prediction of Operational Tolerance
Lead Sponsor:
Hospital Clinic of Barcelona
Collaborating Sponsors:
Fondo de Investigacion Sanitaria
European Commission
Conditions:
Liver Transplantation
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
In liver transplantation up to 20% of recipients can completely discontinue immunosuppressive therapy maintaining normal graft function, and are conventionally considered as operationally tolerant. Di...
Detailed Description
1. This is a prospective study in which liver transplant recipients on maintenance immunosuppression (IS) will undergo carefully supervised IS weaning over a period of approximately 6-9 months. Patien...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Liver transplantation performed for non-autoimmune liver disease performed at least 3 years before IS weaning.
- 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.
- 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.
- Low dose immunosuppression (monotherapy with calcineurin inhibitors, mTOR inhibitors or mycophenolate mofetil, or combined therapy with 2 drugs at very low doses).
- Absence of medical or psychological disturbances that preclude the safe performance of the trial.
- Stability of liver graft function, defined as: normal liver function tests (AST, ALT, ALP, GGT) during at least 6 months, or, alternatively, 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).
- Patients exhibiting at least one of the following characteristics: a) severe side effects of immunosuppressive drugs (diabetes, renal failure, hyperlipidemia, hypertension); b) risk of neoplasm development defined by history of previous non-hepatocarcinoma neoplasms or history of any of the following risk factors: tobacco or alcohol consumption, age greater than 60 years; c) chronic liver disease due to hepatitis C virus infection in patients not receiving anti-viral treatment.
- Signature of informed consent.
Exclusion
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2012
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00647283
Start Date
November 1 2005
End Date
December 1 2012
Last Update
April 20 2011
Active Locations (1)
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1
Hospital Clinic Barcelona, University of Barcelona
Barcelona, Barcelona, Spain, 08036