Comparing Efficacy and Safety of Tacrolimus With Steroids or Monoclonal Anti-IL2R Antibody in Hepatitis C Virus (HCV) Positive Liver Transplant Patients (CHASE)

• Biopsy-proven acute rejection [ Time Frame: 12 months ] [ Designated as safety issue: No ]
• Acute rejection [ Time Frame: 12 months ] [ Designated as safety issue: No ]
• Patient and graft survival [ Time Frame: 12 months ] [ Designated as safety issue: No ]
• Incidence of adverse events [ Time Frame: 12 months ] [ Designated as safety issue: No ]

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.

• Hepatitis C
• Liver Transplantation

• Drug: Tacrolimus
  immunosuppression
  Other Name: Prograf, FK506
• Drug: steroids, monoclonal anti-IL2R antibody
  immunosuppression

• Active Comparator: 1
  Interventions:

  • Drug: Tacrolimus
  • Drug: steroids, monoclonal anti-IL2R antibody
• Experimental: 2
  Intervention: Drug: Tacrolimus

Inclusion Criteria:

• 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 Criteria:

• 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