A Study to Assess the Pharmacokinetics, Safety and Efficacy of Advagraf and Prograf in de Novo Liver Transplantation

Inclusion criteria

• subject receiving a primary, partial liver graft from a living donor
• subject must receive the first dose of tacrolimus and corticosteroids after operation and are expected to be maintained on tacrolimus throughout the study. MMF could be combined

Exclusion criteria

• subjects receiving a multi-organ transplant or having previously received an organ transplant (including liver re-transplantation)
• subjects receiving an auxiliary graft or in whom a bio-artificial liver (cell system) has been used
• subjects allergic or intolerant to macrolide antibiotics or tacrolimus
• subjects requiring immunosuppressive treatment and / or systemic chemotherapy prior to transplantation
• subjects with malignancies or a history of malignancy within the last 5 years, with the exception of those with basalioma or squamous cell carcinoma of the skin
• subjects with systemic infection requiring treatment, except viral hepatitis
• subjects with severe diarrhoea, vomiting, active peptic ulcer or gastrointestinal disorder that may affect the absorption of tacrolimus
• subjects with serum creatinine > 1.5mg/dl
• subjects taking or having taken potassium preserved diuretics
• subjects with any form of substance abuse, psychiatric disorder or condition which, in the opinion of the investigator, may complicate communication with the investigator
• subjects participating or having participated in another clinical trial and/or those taking or having taken an investigational / non-registered drug in the past 28 days
• subjects or donors known to be HIV positive
• donors known to be HBV, HCV positive and/or IgM positive of CMV, EBV