Efficacy and Safety of CertiroBell® Tablet Plus Tacrolimus in Primary Living Donor Liver Transplant Recipients

Phase 4

• Conditions: Liver Transplant
• Interventions: Drug: Everolimus

• Registration Number: NCT04867720
• Lead Sponsor: Chong Kun Dang Pharmaceutical

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.

Study Timeline

• Study Start: 2021-03-16
• Status Verified: 2021-04
• Study First Submitted: 2021-04-29
• Study First Submitted QC: 2021-04-29
• Last Update Submitted: 2021-04-29
• Study First Posted: 2021-04-30
• Last Update Posted: 2021-04-30
• Primary Completion: 2022-10-10
• Study Completion: 2023-02-22

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 112

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CertiroBell Tablet	Everolimus	Use in combination with Tacrolimus at least 6 months after liver transplantation.

Primary Outcome Measures

Name	Time	Method
Incidence of composite efficacy failure	until 24 weeks after taking medicine	composite efficacy failure include biopsy-confirmed acute rejection, graft loss, death, or follow-up failure

Secondary Outcome Measures

Name	Time	Method
Incidence of biopsy-confirmed acute rejection	until 24 weeks after taking medicine	acute rejection confirmed by result of biopsy(over 4 points of RAI score)
Pathological result, time of occurrence, treatment method and treatment result of acute rejection confirmed by biopsy(over 4 points of RAI score)	until 24 weeks after taking medicine	details of acute rejection confiremd by result of biopsy(over 4 points of RAI score)
Survival rate of patients	until 24 weeks after taking medicine	Survival rate of patients
Survival rate of transplanted organ	until 24 weeks after taking medicine	Survival rate of transplanted organ
Incidence rate of liver cancer	until 24 weeks after taking medicine	Incidence rate of liver cancer
Recurrence rate of liver cancer	until 24 weeks after taking medicine	Recurrence rate of liver cancer
Incidence rate of CMV infection	until 24 weeks after taking medicine	Incidence rate of CMV infection
Variation of serum creatinine, eGFR(estimated glomerular filtration rate) compared to baseline using MDRD(Modification of Diet in Renal Disease)	until 24 weeks after taking medicine	eGRF using MDRD(Modification of Diet in Renal Disease) method

Trial Locations

Locations (1)

Seoul National University Hosipital; 🇰🇷 Seoul, Korea, Republic of