Clinical trial NCT04069065: Efficacy and Safety of Once-Daily Tacrolimus in Liver Transplant Recipients (SOUL)
Official title: 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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Liver Transplant
Lead sponsor: Chong Kun Dang Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2019-08-28
Enrollment: 146
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of composite efficacy failure
timeFrame: until 24 weeks
Secondary outcomes:
measure: Incidence of biopsy-confirmed acute rejection
timeFrame: until 24 weeks
measure: Pathological results of acute rejection
timeFrame: until 24 weeks
measure: Survival rate of transplanted organ
timeFrame: at 24 weeks
measure: Survival rate of Patients
timeFrame: at 24 weeks
measure: Serum-Cr, eGFR(estimated glomerular filtration rate)
timeFrame: at 24 weeks
measure: Evaluate safety of TacroBell SR. cap. from number of participants with adverse events
timeFrame: until 24 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
References: