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 for HCV cirrhosis.
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 administration and anti-rejection treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
138
immunosuppression
immunosuppression
Unnamed facility
Prague, Czechia
Unnamed facility
Besançon, France
Unnamed facility
Lyon, France
Viral load of HCV at 12 months post transplantation
Time frame: 12 months
Biopsy-proven acute rejection
Time frame: 12 months
Acute rejection
Time frame: 12 months
Patient and graft survival
Time frame: 12 months
Incidence of adverse events
Time frame: 12 months
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Unnamed facility
Nice, France
Unnamed facility
Villejuif, France
Unnamed facility
Berlin, Germany
Unnamed facility
Hamburg, Germany
Unnamed facility
Mainz, Germany
Unnamed facility
Bologna, Italy
Unnamed facility
Genova, Italy
...and 7 more locations