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

Chong Kun Dang

Status and phase: Unknown; Phase 4

Conditions: Liver Transplant

Treatments: Drug: Everolimus Tab.; Drug: Mycophenolate mofetil Tab./Cap.

Study type: Interventional

Funder types: Industry

Identifiers

NCT04471441

B95-02LT1903

Details and patient eligibility

About

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.

Full description

This study is multi-center, open-label, randomized controlled phase 4 study to evaluate the efficacy and safety of certirobell® tablet compared with mycophenolate mofetil in primary living donor liver transplant recipients.

On the first visit the patients scheduled to be operated liver transplant in 35 days will be conducted screening. Patients who meet the criteria of this clinical trial will be randomized to CertiroBell or mycophenolate mofetil on the second visit. Each group will take CertiroBell or mycophenolate mofetil and will conduct scheduled tests with 5 additional visits.

Enrollment: 150 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

* Inclusion Criteria:

[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)

* Exclusion Criteria

[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

• Patients who had plasmapheresis within 1 week.

• Patents who had a record of taking mTOR inhibitor before.

• In investigator's judgement

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

CertiroBell Tablet

Experimental group

Description:

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

Treatment:

Drug: Everolimus Tab.

Mycophenolate mofetil Tablet/Capsule

Active Comparator group

Description:

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

Treatment:

Drug: Mycophenolate mofetil Tab./Cap.