A Study to Compare the Efficacy and Safety of FK506MR vs Prograf® in Patients Undergoing Liver Transplantation

• Status: Completed
• Trial end date: 2009-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The patients about to undergo liver transplantation will be randomized to one of the following two group:

Group FK506MR: FK506MR/steroid; Group Prograf® : Prograf® /steroid The treatment period is 3 months(12 weeks

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

Details

• Lead Sponsor: Astellas Pharma Inc
• Treatments: Tacrolimus

Criteria

Inclusion Criteria:

• Written informed consent with the date of the patient must be obtained.

• Patient between 18-70 years of age receiving the primary liver.

• Female patients must have a negative pregnancy test prior to the enrolment.

• Female patients of child bearing potential must agree to practice effective birth control during the study

Exclusion Criteria:

• Liver re-transplantation patients or received an organ transplantation other than a liver.

• Living-related liver transplantation patient.

• Patient has received an AB0 incompatible donor liver.

• Patient who needs antibody induction therapy.

• Patient with sever infection requiring treatment.

• Patient has any history of severe cardiovascular, respiratory disease; or history of malignancy, liver cancer not included.