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

Chong Kun Dang

Status and phase: Unknown; Phase 4

Conditions: Liver Transplant

Treatments: Drug: Everolimus

Study type: Interventional

Funder types: Industry

Identifiers

NCT04867720

B95_03LT2001

Details and patient eligibility

About

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

Full 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.

Enrollment: 112 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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112 participants in 1 patient group

CertiroBell Tablet

Experimental group

Description:

Use in combination with Tacrolimus at least 6 months after liver transplantation.

Treatment:

Drug: Everolimus