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AN OPEN, RANDOMISED, MULTICENTRE, EXPLORATORY CLINICAL STUDY TO COMPARE THE SAFETY AND EFFICACY OF TACROLIMUS IN COMBINATION WITH MONOCLONAL ANTI-IL2R ANTIBODIES OR STEROIDS IN HCV POSITIVE PATIENTS U...

Mise à jour : Il y a 4 ans
Référence : EUCTR2004-004561-14

AN OPEN, RANDOMISED, MULTICENTRE, EXPLORATORY CLINICAL STUDY TO COMPARE THE SAFETY AND EFFICACY OF TACROLIMUS IN COMBINATION WITH MONOCLONAL ANTI-IL2R ANTIBODIES OR STEROIDS IN HCV POSITIVE PATIENTS UNDERGOING LIVER ALLOGRAFT TRANSPLANTATION

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Extrait

The objective of this exploratory study is to evaluate the impact of the elimination of the 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 with standard steroid administration and the second with daclizumab (MAB) avoiding steroids for both prophylactic immunosuppression and anti-rejection treatment.

Critère d'inclusion

  • Patients 18 to 65 years of age who will undergo primary orthotopic liver or split liver allograft transplantation for HCV-cirrhosis. As the primary endpoint of the study is the viral load of HCV the below indicated code-level refers to 'Hepatitis C positive'

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