A Study to Evaluate the Safety and Effectiveness of FK778 in Liver Transplant Patients

A Multicentre, Randomised, Double-Blind, Tacrolimus Dual Therapy-Controlled, Parallel Group, Multiple Oral Dose Study to Evaluate the Safety, Tolerability, Efficacy and Pharmacokinetics of FK778 in Liver Transplant Patients Receiving Standard Tacrolimus (FK506) and Steroids Therapy

A proof of concept study to evaluate the safety and effectiveness of FK778 in liver transplant patients.

Inclusion Criteria:

• Male or female patients at least 18 years of age and not older than 65 years.
• Female patients of child bearing potential must have a negative serum pregnancy test prior to enrollment and must agree to practice effective birth control during the study.
• Male patients must agree to practice effective birth control methods during the study.
• Patient is a recipient of a primary whole cadaveric liver transplant

Exclusion Criteria:

• Patient has previously received or is receiving an organ transplant other than a liver.
• Patient has received an ABO incompatible donor liver.
• Patient or donor is known to be HIV positive.
• Patient has a current malignancy or a history of malignancy (within the past 5 years), except non-metastatic basal or squamous cell carcinoma of the skin that has been treated successfully.
• Patient is being transplanted for hepatic malignancy with a single nodule greater than 5.0 cm in diameter or 2 or more nodules with at least one > 3.0 cm.
• Patient has a serum creatinine >175 µmol/L at baseline. Patient has uncontrolled concomitant infections and/or severe diarrhoea, vomiting, active upper gastro-intestinal tract malabsorption or an active peptic ulcer or any other unstable medical condition that could interfere with the study objectives.
• Patient who is receiving or may require warfarin or fluvastatin during the study.
• Patient is participating in another clinical trial and/or is taking or has been taking an investigational drug in the 28 days prior to transplant