Status:
TERMINATED
Induction Treatment Followed by Immunosuppression Withdrawal in Liver Transplantation: A Comparative Trial
Lead Sponsor:
Hospital Clinic of Barcelona
Collaborating Sponsors:
Fresenius AG
Astellas Pharma Inc
Conditions:
Liver Diseases
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is a randomized, controlled trial in liver transplantation in which conventional immunosuppressive treatment will be compared with a therapeutic strategy consisting in pre-transplant antibody-med...
Detailed Description
This is an open-label randomised controlled study in which patients will be randomised according to a 1:1 ratio to receive conventional immunosuppressive treatment or induction treatment plus reduced ...
Eligibility Criteria
Inclusion
- Age \> 18 years
- Recipient of a primary liver graft
- Absence of any of our exclusion criteria
Exclusion
- Pretransplant renal failure, defined as serum creatinine \> 1.5 mg/dL
- Severe pretransplant thrombopenia, defined as platelets \< 50000/mL
- Combined liver-kidney transplantation
- Autoimmune hepatitis, primary biliary cirrhosis or primary sclerosing cholangitis as causes of liver transplantation
- Chronic hepatic encephalopathy
- Living donor liver transplantation
- Recipient with human immunodeficiency virus infection
- Severe pretransplant leukopenia, defined as \< 1500 leukocytes/mL
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT00436722
Start Date
June 1 2006
Last Update
May 20 2009
Active Locations (1)
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1
Hospital Clinic Barcelona, University of Barcelona
Barcelona, Spain, 08036