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

Liver Transplant Clinical Trial

— MONTBLANC  

Official title:

Multi-center, Open-label, Randomized Controlled Phase 4 Study to Evaluate the Efficacy and Safety of CertiroBell® Compared With Mycophenolate Mofetil in Primary Living Donor Liver Transplant Recipients.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04471441
• Other study ID #: B95-02LT1903
• Status: Recruiting
• Phase: Phase 4
• Start date: June 30, 2020
• Est. completion date: November 17, 2022

Study information

• Verified date: July 2020
• Source: Chong Kun Dang Pharmaceutical
• Contact: Soon Il Kim, M.D., Ph.D.
• Phone: 82-2-2228-2131
• Email: SOONKIM[@]YUHS.AC
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: November 17, 2022
• Est. primary completion date: September 13, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

• 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

Related Conditions & MeSH terms

• Liver Transplant

Intervention

Drug:
• Everolimus Tab.
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.
• Mycophenolate mofetil Tab./Cap.
Up to 1.5g BID(total 3g daily), PO

Locations

Country	Name	City	State
Korea, Republic of	Severance Hospital	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 24weeks and 48weeks after taking medicine
Secondary	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)	details of acute rejection confirmed by result of biopsy(over 4 points of RAI score)	until 24weeks and 48weeks after taking medicine
Secondary	Incidence of composite efficacy failure	composite efficacy failure include biopsy-confirmed acute rejection, graft loss, death, or follow-up failure	until 48weeks after taking medicine
Secondary	Survival rate of patients	Survival rate of patients	until 24weeks and 48weeks after taking medicine
Secondary	Survival rate of transplanted organ	Survival rate of transplanted organ	until 24weeks and 48weeks after taking medicine
Secondary	Incidence and recurrence rates of liver cancer	Incidence and recurrence rates of liver cancer	until 24weeks and 48weeks after taking medicine
Secondary	Incidence and recurrence rates of HCV infection	Incidence and recurrence rates of HCV infection	until 24weeks and 48weeks after taking medicine
Secondary	Incidence of CMV infection	Incidence of CMV infection	until 24weeks and 48weeks after taking medicine
Secondary	variation of Serum creatinine, eGFR(estimated glomerular filtration rate) compared to the baseline	eGFR using MDRD(Modification of Diet in Renal Disease) method	at 24 weeks and 48weeks