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

• Status: Completed
• Trial end date: 2008-06-01
• Target enrollment: 0
• Participant gender: All

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 for HCV cirrhosis.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Astellas Pharma Inc
• Treatments: Antibodies; Immunoglobulins; Tacrolimus

Criteria

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