Overview

A Study to Evaluate the Safety and Efficacy of FK506E (MR4) in Patients Undergoing Primary Liver Transplantation.

Status:
Completed
Trial end date:
2006-12-01
Target enrollment:
Participant gender:
Summary
To evaluate and to compare efficacy and safety of a dual regimen with oral modified release tacrolimus FK506E (MR4) / steroids versus a dual regimen with oral tacrolimus FK506 / steroids in patients undergoing primary liver transplantation. It shall be demonstrated that FK506E (MR4) is non-inferior to FK506 with regards to the primary endpoint.
Phase:
Phase 3
Details
Lead Sponsor:
Astellas Pharma Inc
Treatments:
Tacrolimus