Clinical trial NCT04867720: Efficacy and Safety of CertiroBell® Tablet Plus Tacrolimus in Primary Living Donor Liver Transplant Recipients
Official title: Multi-center, Single Arm, Open-label, Phase 4 STudy to Evaluate the Efficacy and Safety of CertiroBELL® Tablet Plus TAcrolimus in Primary Living Donor Liver Transplant Recipients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Liver Transplant
Keywords: Everolimus
CertiroBell
Tacrolimus
Lead sponsor: Chong Kun Dang Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2021-04-30
Enrollment: 112
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: To evaluate the efficacy and safety of CertiroBell® tablet plus tacrolimus

Detailed description: This study is multi-center, single arm, open-label, phase 4 study to evaluate the efficacy and safety of CertiroBell® tablet plus tacrolimus in primary living donor liver transplant recipients.

Eligibility criteria: Inclusion Criteria:

1. Patients who had liver transplantation from living donor and had passed over 3 months since operation.
2. Over 20 years old
3. Patients who are being treated with Tacrolimus at screening visit
4. Patients who agreed to written informed consent

Exclusion Criteria:

1. Patients who had received non-liver organs before liver transplantation or had received other organs while receiving liver.
2. Patients who had auxiliary partial orthotopic liver transplantation or had bioartifical liver
3. Patients who have been diagnosed with acute rejection within 6 months and have been treated
4. Patients who had hepatic artery complication such as hepatic artery thrombosis within recent 6 months
5. Patients who have been diagnosed with malignant tumor within 5 years(however, the following will be excepted)

   * fully recovered from skin cancer(squamous cell/basal cell carcinoma or thyroid cancer)
   * haptocellular carcinoma without main vessel invasion
6. Patients with severe systemic infection
7. Patients who are difficult to communicate due to mental disorder
8. Patients who are in treatment for hapatitis, or are over 3 times higher than upper normal limit in liver function test(T-bilirubin, AST, ALT) or over 5 times higher than normal limit of ALP
9. Patients who are(at screening visit)

   * WBC\<1,500/mm\^3
   * PLT\<30,000/mm\^3
   * over 1.0 in Protein/creatinine ratio(UA test)
   * eGFR\<30mL/min/1.73m\^2(MDRD)
   * Total Cholesterol\>350mg/dL or Triglycerides\>500mg/dL
10. Patients taking HCV(hapatitis C virus) therapeutic drug or anti-HCV positive patients who have positive result in HCV RNA test at screening visit
11. Patients who had plasmapheresis within 1 week
12. Those who are pregnant, nursing, or are not practicing contraception with appropriate method
13. Patients who had plasmapheresis within 3 months
14. if participated in other trail within 4 weeks(28 days)
15. In investigator's judgement

Primary outcomes:
measure: Incidence of composite efficacy failure
timeFrame: until 24 weeks after taking medicine
Secondary outcomes:
measure: Incidence of biopsy-confirmed acute rejection
timeFrame: until 24 weeks after taking medicine
measure: Pathological result, time of occurrence, treatment method and treatment result of acute rejection confirmed by biopsy(over 4 points of RAI score)
timeFrame: until 24 weeks after taking medicine
measure: Survival rate of patients
timeFrame: until 24 weeks after taking medicine
measure: Survival rate of transplanted organ
timeFrame: until 24 weeks after taking medicine
measure: Incidence rate of liver cancer
timeFrame: until 24 weeks after taking medicine
measure: Recurrence rate of liver cancer
timeFrame: until 24 weeks after taking medicine
measure: Incidence rate of CMV infection
timeFrame: until 24 weeks after taking medicine
measure: Variation of serum creatinine, eGFR(estimated glomerular filtration rate) compared to baseline using MDRD(Modification of Diet in Renal Disease)
timeFrame: until 24 weeks after taking medicine
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hosipital
Study officials:
affiliation: Seoul National University Hospital
name: Kyung-Suk Suh, M.D., Ph.D.
role: STUDY_CHAIR
References: