A Study to Compare Safety and Efficacy of Prograf + Myfortic and Advagraf + Myfortic in Liver Transplantation Patients

• Status: Completed
• Trial end date: 2010-12-01
• Target enrollment: 0
• Participant gender: All

Summary

To compare the safety and efficacy of Prograf® with Myfortic® to Advagraf® extended release tacrolimus with Myfortic® in de novo liver transplant recipients.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Astellas Pharma Inc
• Collaborator: Astellas Pharma Taiwan, Inc.
• Treatments: Mycophenolate mofetil; Mycophenolic Acid; Tacrolimus

Criteria

Inclusion Criteria:

• Patient is a primary liver transplant recipient

• Female patients of child bearing potential must have a negative urine or serum pregnancy test within 7 days prior to transplant

• Patient has been fully informed and has signed an IRB approved informed consent form and is willing and able to follow study procedures

• Patient must receive 1st dose of study drug within 24 hours of pre-transplantation

Exclusion Criteria:

• Patient has previously received or is receiving an organ transplant other than a liver

• Patient currently requires dialysis

• Patient has received a liver transplant from a non-heart beating donor

• Patient has received an ABO incompatible donor liver

• Recipient or donor is known to be seropositive for human immunodeficiency virus (HIV)

• Patient has fulminant hepatic failure, unless hemodynamically stable

• Patient has an uncontrolled concomitant infection, a systemic infection requiring treatment (except viral hepatitis), or any other unstable medical condition that could interfere with the study objectives

• Patient is currently taking or has been taking an investigational drug in the 30 days prior to transplant

• Patient has a known hypersensitivity to tacrolimus, enteric-coated mycophenolate sodium or corticosteroids

• Patient is pregnant or lactating