Tacrolimus and Daclizumab Versus Tacrolimus and Steroids in Liver Recipients Receiving Sub-optimal Grafts

• Status: Completed
• Trial end date: 2007-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to compare the safety and efficacy of two different tacrolimus based immunosuppressive regimens, one in combination with daclizumab, the other in combination with steroids, in recipients of suboptimal livers.

Pharmacokinetics of tacrolimus and bile composition will be measured in a subgroup of patients.

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

Details

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

Criteria

Inclusion Criteria:

• Signed informed consent

• Adult patients scheduled to receive a liver transplant

• Donors older than 65 and/or has liver macrosteatosis >15%

• Female patients of childbearing potential agree to maintain effective birth control during the study and must have negative pregnancy test at baseline

Exclusion Criteria:

• Patient has previously received or is receiving an organ transplant other than liver, or a liver re-transplantation.

• Patient has significant, uncontrolled concomitant infections and/or severe diarrhea, vomiting, or active peptic ulcer

• Patient is receiving an auxiliary graft or a bio-artificial liver has been used.

• Any pathology or medical condition that can interfere with this protocol study proposal

• Other exclusion applies