Efficacy and Safety of Once-Daily Tacrolimus in Liver Transplant Recipients (SOUL)

Multi Center, Non-comparative, Phase IV Study to Evaluate the Efficacy and Safety of Conversion to TacroBell SR Cap.(Once-Daily Tacrolimus) in Patients Undergoing Maintenance Therapy With Twice-Daily Tacrolimus After Liver Transplantation.

The purpose of this study is to evaluate the efficacy and safety of conversion to TacroBell slow-release cap.(Once-daily Tacrolimus) in patients undergoing maintenance therapy with Twice-Daily Tacrolimus after liver transplantation.

This study is a multi-center, non-comparative, and phase IV clinical trial that evaluates the efficacy and safety of conversion to TacroBell slow-release cap.(Once-daily Tacrolimus) in patients who have undergone at least one year after liver transplantation and receive maintenance therapy with Twice-Daily Tacrolimus.

Enrolled subjects will take TacroBell slow-release cap.(Once-daily Tacrolimus) for 24 weeks and will conduct scheduled tests with four additional visits.

Inclusion Criteria:

• At least one year after liver transplantation
• Over 20 years old(male or female)
• Patient taking tacrolimus twice daily as a maintenance therapy
• Patients with Tacrolimus blood levels of 3-10 at screening
• Agreement with written informed consent

Exclusion Criteria:

• Previously transplanted another organs other than the liver or at the same time

• Diagnosed and clinically treated with acute rejection within the last 6 months

• Patients who have changed the method of administering concomitant immunosuppressants or steroids within the last month

• Diagnosed with cancer in the last five years [Patients, however, who have recovered from skin cancer (squamous cell/basal cell carcinoma) or thyroid cancer, hepatocellular carcinoma without main vessel invasion or extrahepatic metastasis can be enrolled]

• Patients who have positive HIV test result

• Severe systemic infection requiring treatment

• At screening

  • White blood cell count < 1,500/mm^3, or platelet < 50,000/mm^3, or Serum-C r> 2.0mg/dl
  • Liver function test(T-bilirubin, aspartate aminotransferase, alanine aminotransferase)is over 3 times than upper normal limit

• Patients Taking HCV(hepatitis C virus) Therapeutic Drugs

• Pregnant women or nursing mothers

• Fertile women who not practice contraception with appropriate methods

• Participated in other trial within 4 weeks

• In investigator's judgment