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

Phase 4
Conditions
Liver Transplant
Interventions
Drug: Conversion to Once-daily Tacrolimus
Registration Number
NCT04069065
Lead Sponsor
Chong Kun Dang Pharmaceutical
Brief Summary

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

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.

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
146
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
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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

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Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Conversion to Once-daily TacrolimusConversion to Once-daily TacrolimusConversion to TacroBell slow-release cap.(Once-daily Tacrolimus) at least one year after liver transplantation
Primary Outcome Measures
NameTimeMethod
Incidence of composite efficacy failureuntil 24 weeks

composite efficacy failure include biopsy-confirmed acute rejection, graft loss, death, or follow-up failure

Secondary Outcome Measures
NameTimeMethod
Pathological results of acute rejectionuntil 24 weeks

acute rejection using Banff 2016 Criteria and RAI(Rejection activity index) score; total 0\~9

Evaluate safety of TacroBell SR. cap. from number of participants with adverse eventsuntil 24 weeks
Incidence of biopsy-confirmed acute rejectionuntil 24 weeks

episode of biopsy-confirmed acute rejection until 24weeks after conversion

Survival rate of transplanted organat 24 weeks
Survival rate of Patientsat 24 weeks
Serum-Cr, eGFR(estimated glomerular filtration rate)at 24 weeks

eGFR using MDRD(Modification of Diet in Renal Disease) method

Trial Locations

Locations (1)

Samsung Medical Center

🇰🇷

Seoul, Korea, Republic of

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