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

NCT04867720 | Unknown Phase 4

• 1 other identifier: B95_03LT2001
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Liver Transplant

Keywords

Everolimus; CertiroBell; Tacrolimus

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Incidence of biopsy-confirmed acute rejection

  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)

  until 24 weeks after taking medicine

• Survival rate of patients

  until 24 weeks after taking medicine

• Survival rate of transplanted organ

  until 24 weeks after taking medicine

• Incidence rate of liver cancer

  until 24 weeks after taking medicine

Study Arms (1)

CertiroBell Tablet

EXPERIMENTAL

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

Drug: Everolimus

Interventions

Everolimus DRUG

\- 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.

Also known as: CertiroBell Tab.

CertiroBell Tablet

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who had liver transplantation from living donor and had passed over 3 months since operation.
• Over 20 years old
• Patients who are being treated with Tacrolimus at screening visit
• Patients who agreed to written informed consent

You may not qualify if:

• Patients who had received non-liver organs before liver transplantation or had received other organs while receiving liver.
• Patients who had auxiliary partial orthotopic liver transplantation or had bioartifical liver
• Patients who have been diagnosed with acute rejection within 6 months and have been treated
• Patients who had hepatic artery complication such as hepatic artery thrombosis within recent 6 months
• 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
• Patients with severe systemic infection
• Patients who are difficult to communicate due to mental disorder
• 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
• 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)

Sponsors & Collaborators

• Chong Kun Dang Pharmaceutical: lead

Study Sites (1)

Seoul National University Hosipital

Seoul, South Korea

RECRUITING

MeSH Terms

Interventions

Everolimus

Intervention Hierarchy (Ancestors)

Sirolimus; Macrolides; Lactones; Organic Chemicals

Study Officials

• Kyung-Suk Suh, M.D., Ph.D.

  Seoul National University Hospital

  STUDY CHAIR

Central Study Contacts

Kyung-Suk Suh, M.D., Ph.D.

CONTACT

82-2-2072-7200; kssuh@snu.ac.kr

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2021
• First Posted: April 30, 2021
• Study Start: March 16, 2021
• Primary Completion: October 10, 2022
• Study Completion: February 22, 2023
• Last Updated: April 30, 2021

Record last verified: 2021-04

Locations

KR (1)