Evaluate the Efficacy and Safety of the ADVAGRAF®
Condition: Evidence of Liver Transplantation
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary objective of this study is to evaluate the efficacy of 6-month treatment with
      Advagraf® converted from 12-month treatment with tacrolimus in stable liver transplant
      recipients.

      The secondary objective of this study is to evaluate severity of acute rejection confirmed by
      biopsy in 24 weeks, incidence of chronic rejection, patient and graft survival rates in 24
      weeks, incidence of adverse events, blood pressure, tacrolimus trough level, drug compliance,
      and adherence.
    

Detailed description: 
      This is single-center, single-group, open-label study, phase 4 IIT. The Subject is
      transplantated liver at a minimum of 12 month of screening and at least 12 month Treatment
      with a Tacrolimus stably And start screening after obtain consent to participate in clinical
      trials, if appropriate in the selection criteria do not apply to the exclusion criteria are
      enrolled in clinical trials.

      Administration method is following : The total daily dose of -1 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 for 24 weeks, starting from Day 0.

      Researchers must check the blood concentration of tacrolimus at each visit and adjust the
      dose to achieve the blood concentration maintaining at 5~10ng/ml of study treatment.

      Duration of treatment : The investigational product will be administered for 24 weeks.

      Tacrorimus blood level is 3-10 ng/ml for 6 months prior to screening and during the
      maintenance therapy. It is recommended to check the blood concentration of tacrolimus at each
      visit and adjust the dose to achieve the blood concentration maintaining at 5~10ng/ml of
      study treatment. (The lowest blood levels shall be adjusted at the discretion of the
      researchers, taking a blood sample is carried out in the morning before have of
      Investigational Product)

      Subjects, who participated in this clinical trial, are scheduled up to 5 times, and it will
      be proceed for 24 weeks. (screening and baseline, 3 weeks, 12 weeks, 24 weeks) admitted for
      24 weeks including a screening visit.
    

Intervention name(s): Advagraf
Intervention type(s): Drug
Intervention description(s): Researchers must check the blood concentration of tacrolimus at each visit and adjust the dose to achieve the blood concentration maintaining at 5~10ng/ml of study treatment. Duration of treatment The investigational product will be administered for 24 weeks. (The lowest blood levels shall be adjusted at the discretion of the researchers, taking a blood sample is carried out in the morning before administrated of Investigational Product)
Tacrolimus blood level is 3-10 ng/ml for 6 months prior to screening and during the maintenance therapy.
( ① -1day to enrollment : swich to the day before ADVAGRAF®, ② 0day to enrollment : the day swich to ADVAGRAF® )
Duration of treatment the investigational product will be administered for 24 weeks.
Other intervention name(s): tacrolimus
Intervention MeSH terms: Tacrolimus
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: ADVGRAF®, Liver transplantation, tacrolimus.