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

• Status: Recruiting
• Trial end date: 2023-02-22
• Target enrollment: 0
• Participant gender: All

Summary

To evaluate the efficacy and safety of CertiroBell® tablet plus tacrolimus

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chong Kun Dang Pharmaceutical
• Treatments: Everolimus

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