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

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