To Evaluate the Efficacy and Safety of ADVAGRAF® After Treatment With a Tacrolimus in New Liver Transplant Recipients

This is single center,open-label study with ADVAGRAF® Primary endpoint is Incidence rate of biopsy confirmed acute rejection reactions within 24 weeks following conversion+ Incidence rate of acute rejection reactions (%) = number of subjects with at least one acute rejection reaction 1)/total number of subjects in the relevant analysis set * 100 Only those acute rejection reactions confirmed by biopsy will be acceptable as acute rejection reactions.

Administration method is following The total daily dose of tacrolimus will be converted to 1:1 (mg:mg) and the total daily dose of ADVAGRAF® will be administered only once daily in the morning, starting from Day 1 (at least one hour before breakfast or 2 to 3 hours after breakfast).

• Dose adjustment after conversion On Day 1, the total dose will be converted to 1:1. It is recommended to check the blood concentration of tacrolimus at each visit and adjust the dose to achieve the blood concentration maintaining at 5~8ng/ml for 0 to 3 months and then at 5ng/ ml or below for 3 to 6 months of study treatment.
• Duration of treatment The investigational product will be administered for 24 weeks.

Inclusion criteria

• When the Subjects agree informed consent form, Subject should be More than 20 years of age
• Those who was transplanated liver at a minimum of 10 weeks or Maximum of 14 weeks before the baseline
• Average of tacrorimus minimum blood concenration level is 3-10 ng/mL from transplanted date to baseline.
• Female subjects who have child bearing potential must have a negative at urine or serum pregnancy test prior to enrollment and must agree to practice effective contraceptive measures during the study.(The oral contraceptive pill is not allowed to take a female subject)
• Subjects who are clinically stable judged by investigator.
• Subjects capable of understanding the purpose and risks of the study, having been fully informed and has given written informed consent to participate in the study

Exclusion criteria

• Subjects previously received an organ transplantation excluding liver transplantation. Or Subjects received an auxiliary graft or bioartificial liver(cell system).
• Recently there was acute rejection from the day of liver transplantation to baseline
• If the onset of a new malignant cancer after liver transplantation is diagnosed, well treated basal cell carcinoma or squamous cell carcinoma is classified as an exception
• When it is known that there is a hypersensitivity reaction to the ingredients of tacrolimus or the test drug
• In the opinion of the investigator, there is an unstable medical condition that can affect the purpose of the clinical trial
• In the event of material abuse, mental disorder or anything that can not smoothly communicate with the inverstigator in the opinion of the investigator
• Currently, if subjects are participating in other clinical trials or if subjects receive another drug for clinical trials within 28 days before baseline
• If subjects have received a prohibited combination therapy currently or within 28 days before the baseline
• Pregnant or lactating women
• If known for HIV-positive
• When there is a high possibility that subject will not be able to obey the visit schedule planned in protocol
• Those who have clinically significant renal dysfunction judged by the investigator or at baseline serum creatinine level exceeds 1.6 mg / dL or GFR (MDRD) is less than 30 mL / min
• Those who have clinically significant liver function disorder judged by the investigator or at the baseline, the values of SGPT / ALT and / or SGOT / AST and / or bilirubin are more than three times the upper limit of the laboratory normal range When raised