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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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.

Conditions
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Liver Transplant

Intervention / Treatment
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* Drug: Conversion to Once-daily Tacrolimus


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Conversion to Once-daily Tacrolimus<br>Conversion to TacroBell slow-release cap.(Once-daily Tacrolimus) at least one year after liver transplantation | Drug: Conversion to Once-daily Tacrolimus<br>* Orally, once-daily in the morning The first dose is converted to approximately 100% of the existing daily dose, taking into account the subject's blood concentration, after which the investigator check the blood concentration of tacrolimus at each visit and adjust the dose to achieve the blood concentration maintaining at 3 10ng/ml.<br>* Other names: TacroBell slow-release cap.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of composite efficacy failure | composite efficacy failure include biopsy-confirmed acute rejection, graft loss, death, or follow-up failure | until 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of biopsy-confirmed acute rejection | episode of biopsy-confirmed acute rejection until 24weeks after conversion | until 24 weeks | 
| Pathological results of acute rejection | acute rejection using Banff 2016 Criteria and RAI(Rejection activity index) score; total 0 9 | until 24 weeks | 
| Survival rate of transplanted organ |  | at 24 weeks | 
| Survival rate of Patients |  | at 24 weeks | 
| Serum-Cr, eGFR(estimated glomerular filtration rate) | eGFR using MDRD(Modification of Diet in Renal Disease) method | at 24 weeks | 
| Evaluate safety of TacroBell SR. cap. from number of participants with adverse events |  | until 24 weeks |