Comparing Efficacy & Safety of Tacrolimus With/Without MMF or Monoclonal Anti-IL2R Antibody in Liver Transplantation.

• Status: Completed
• Trial end date: 2007-06-01
• Target enrollment: 0
• Participant gender: All

Summary

To compare the efficacy and safety of two regimens containing tacrolimus and minimal steroids together with either monoclonal anti-IL2R antibodies (daclizumab) or mycophenolate mofetil.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria:

• Patients 18 years of age or older who will undergo primary orthotopic liver or split liver allograft transplantation are eligible for the study. Patients receiving a liver transplant from cadaveric heart-beating donor with compatible AB0 blood type can be included.

Exclusion Criteria:

• Recipient of an auxiliary graft

• Patient is requiring initial sequential or parallel therapy with other immunosuppressive antibody preparation(s).

• Patient is requiring ongoing dosing with corticosteroids.

• Patient is exhibiting symptoms of, or is having any previous history of neoplastic disease

• Patient or donor is known to be HIV positive.

• Patient is allergic or intolerant to study medication