Status:
COMPLETED
Comparing Efficacy and Safety of Tacrolimus With Steroids or Monoclonal Anti-IL2R Antibody in Hepatitis C Virus (HCV) Positive Liver Transplant Patients
Lead Sponsor:
Astellas Pharma Inc
Conditions:
Hepatitis C
Liver Transplantation
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
This is an exploratory study to evaluate the impact of eliminating steroid administration upon viral HCV load at 12 months measured by quantitative serum HCV-RNA determination in patients transplanted...
Detailed Description
A comparison will be made between two regimens which both include tacrolimus, one utilizing standard steroid administration and the second with daclizumab (MAB) avoiding steroids for both prophylactic...
Eligibility Criteria
Inclusion
- Patients 18 to 65 years of age who will undergo primary orthotopic liver or split liver allograft transplantation for HCV-cirrhosis are eligible for the study.
- Patients receiving a cadaveric liver transplant with compatible ABO blood type can be included.
Exclusion
- Recipient of multi-organ transplant
- Recipient of an auxiliary graft
- Patient is receiving ABO incompatible graft
- Patients requiring immunosuppressive treatment
- Patients requiring ongoing corticosteroid therapy.
- Patient has significant, uncontrolled concomitant infections and/or severe diarrhoea, vomiting, active upper gastro-intestinal tract malabsorption or active peptic ulcer.
- Patient or donor is known to be HIV positive.
- Patient is allergic or intolerant to study medication
- Patient is pregnant or breast-feeding.
- Patient has been previously enrolled in this study
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2008
Estimated Enrollment :
138 Patients enrolled
Trial Details
Trial ID
NCT00295607
Start Date
June 1 2005
End Date
June 1 2008
Last Update
April 11 2013
Active Locations (17)
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1
Prague, Czechia, 140 21
2
Besançon, France, 25030
3
Lyon, France, 69317
4
Nice, France, 06202