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

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

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

Study Overview

• Status: Recruiting
• Conditions: Liver Transplant
• Intervention / Treatment: Drug: Everolimus

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 Type: Interventional
• Enrollment (Anticipated): 112
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Kyung-Suk Suh, M.D., Ph.D.; Phone Number: 82-2-2072-7200; Email: kssuh@snu.ac.kr

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Recruiting
    • Seoul National University Hosipital
    • Contact: Kyung-Suk Suh, M.D.,Ph.D.; Phone Number: 82-2-2072 7200; Email: kssuh@snu.ac.kr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CertiroBell Tablet; Use in combination with Tacrolimus at least 6 months after liver transplantation.	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.; Other Names: CertiroBell Tab.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Survival rate of patients	Survival rate of patients	until 24 weeks after taking medicine
Survival rate of transplanted organ	Survival rate of transplanted organ	until 24 weeks after taking medicine
Incidence rate of liver cancer	Incidence rate of liver cancer	until 24 weeks after taking medicine
Recurrence rate of liver cancer	Recurrence rate of liver cancer	until 24 weeks after taking medicine
Incidence rate of CMV infection	Incidence rate of CMV infection	until 24 weeks after taking medicine
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

Collaborators and Investigators

• Sponsor: Chong Kun Dang Pharmaceutical
• Investigators: Study Chair: Kyung-Suk Suh, M.D., Ph.D., Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 16, 2021
• Primary Completion (Anticipated): October 10, 2022
• Study Completion (Anticipated): February 22, 2023

Study Registration Dates

• First Submitted: April 29, 2021
• First Submitted That Met QC Criteria: April 29, 2021
• First Posted (Actual): April 30, 2021

Study Record Updates

• Last Update Posted (Actual): April 30, 2021
• Last Update Submitted That Met QC Criteria: April 29, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Everolimus; Tacrolimus; CertiroBell
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Everolimus
• Other Study ID Numbers: B95_03LT2001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No