Efficacy and Safety of Everolimus Versus Mycophenolate Mofetil in Liver Transplant Recipients.

NCT04471441 | Completed Phase 4

• 1 other identifier: B95-02LT1903
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of CertiroBell® tablet compared with mycophenolate mofetil in primary living donor liver transplant recipients.

Conditions

Liver Transplant

Keywords

Everolimus; CertiroBell; Mycophenolate mofetil

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 (9)

• Incidence of biopsy-confirmed acute rejection

  until 24weeks and 48weeks after taking medicine

• The pathological results and time of occurrence and method of treatment, result of the treatment of acute rejection confirmed by biopsy(over 4 points of RAI score)

  until 24weeks and 48weeks after taking medicine

• Incidence of composite efficacy failure

  until 48weeks after taking medicine

• Survival rate of patients

  until 24weeks and 48weeks after taking medicine

• Survival rate of transplanted organ

  until 24weeks and 48weeks after taking medicine

Study Arms (2)

CertiroBell Tablet

EXPERIMENTAL

De novo liver transplant recipients will be randomized after liver transplant operation.

Drug: Everolimus Tab.

Mycophenolate mofetil Tablet/Capsule

ACTIVE COMPARATOR

De novo liver transplant recipients will be randomized after liver transplant operation.

Drug: Mycophenolate mofetil Tab./Cap.

Interventions

Everolimus Tab. DRUG

After first dose 1mg BID(total 2mg daily PO), check the blood concentration of everolimus at each visit and adjust the dose to acheive the blood concentration maintaining at 3\~8ng/mL.

Also known as: CertiroBell Tab.

CertiroBell Tablet

Mycophenolate mofetil Tab./Cap. DRUG

Up to 1.5g BID(total 3g daily), PO

Mycophenolate mofetil Tablet/Capsule

Eligibility Criteria

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

You may qualify if:

• \[Time of screening\]
• Patients who have transplanted in primary living donor liver in 35 days or who plan to be transplanted in primary living donor liver.
• Over 20 years old(male or female)
• Agreement with written informed consent
• \[Time of randomization\] - Patients who have transplanted liver within 4 weeks(25 days to 35 days)

You may not qualify if:

• \[Time of screening\]
• Patients who have transplanted non-liver organs or have plan to be transplanted non-liver organs.
• Patients with bioartificial liver (cell system)
• Patients who diagnosed with malignant tumor within 5 years \[however, who have recovered from skin cancer (squamous cell/basal cell carcinoma) or thyroid cancer, hepatocellular carcinoma without main vessel invasion or extrahepatic metastasis can be enrolled\]
• Patients with severe systemic infection
• Women who are pregnant or breast feeding or not agree to the proper use of contraception during the trial
• Participated in other trial within 4 weeks
• In investigator's judgement
• \[Time of randomization\]
• Patients with acute rejection who have been clinically treated after liver transplantation.
• Patients with complication related to the hepatic artery such as hepatic artery thrombosis at the time of randomization.
• At screening
• WBC \<1,500/mm\^3 or PLT \<30,000/mm\^3 or over 3 times upper than normal range of liver function tests(T-bilirubin, AST, ALT) levels
• Protein/Creatinine ratio(urine test) \> 1 or eGFR by MDRD\< 30mL/min/1.73m\^2 or Total cholesterol \> 350mg/dL or triglycerides \> 500mg/dL
• Patients taking HCV(hepatitis C virus) Therapeutic Drugs

Sponsors & Collaborators

• Chong Kun Dang Pharmaceutical: lead

Study Sites (1)

Severance Hospital

Seoul, South Korea

Location

MeSH Terms

Interventions

Everolimus

Intervention Hierarchy (Ancestors)

Sirolimus; Macrolides; Lactones; Organic Chemicals

Study Officials

• Dong Jin Joo, M.D., Ph.D.

  Severance Hospital

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: July 10, 2020
• First Posted: July 15, 2020
• Study Start: June 30, 2020
• Primary Completion: July 24, 2024
• Study Completion: July 24, 2024
• Last Updated: April 15, 2026

Record last verified: 2025-02

Locations

KR (1)