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

Liver Transplant Clinical Trial

— STELLA  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04867720
• Other study ID #: B95_03LT2001
• Status: Recruiting
• Phase: Phase 4
• Start date: March 16, 2021
• Est. completion date: February 22, 2023

Study information

• Verified date: April 2021
• Source: Chong Kun Dang Pharmaceutical
• Contact: Kyung-Suk Suh, M.D., Ph.D.
• Phone: 82-2-2072-7200
• Email: kssuh[@]snu.ac.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 112
• Est. completion date: February 22, 2023
• Est. primary completion date: October 10, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Liver Transplant

Intervention

Drug:
• Everolimus
- Oral intake, BID - After first dose 1mg(total 2mg daily), check the blood concentration of everolimus at each visit and adjust the dose to achieve the blood concentration maintaining at 3~8mg/mL.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hosipital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Chong Kun Dang Pharmaceutical

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of composite efficacy failure	composite efficacy failure include biopsy-confirmed acute rejection, graft loss, death, or follow-up failure	until 24 weeks after taking medicine
Secondary	Incidence of biopsy-confirmed acute rejection	acute rejection confirmed by result of biopsy(over 4 points of RAI score)	until 24 weeks after taking medicine
Secondary	Pathological result, time of occurrence, treatment method and treatment result of acute rejection confirmed by biopsy(over 4 points of RAI score)	details of acute rejection confiremd by result of biopsy(over 4 points of RAI score)	until 24 weeks after taking medicine
Secondary	Survival rate of patients	Survival rate of patients	until 24 weeks after taking medicine
Secondary	Survival rate of transplanted organ	Survival rate of transplanted organ	until 24 weeks after taking medicine
Secondary	Incidence rate of liver cancer	Incidence rate of liver cancer	until 24 weeks after taking medicine
Secondary	Recurrence rate of liver cancer	Recurrence rate of liver cancer	until 24 weeks after taking medicine
Secondary	Incidence rate of CMV infection	Incidence rate of CMV infection	until 24 weeks after taking medicine
Secondary	Variation of serum creatinine, eGFR(estimated glomerular filtration rate) compared to baseline using MDRD(Modification of Diet in Renal Disease)	eGRF using MDRD(Modification of Diet in Renal Disease) method	until 24 weeks after taking medicine