Clinical trial NCT04471441: Efficacy and Safety of Everolimus Versus Mycophenolate Mofetil in Liver Transplant Recipients.
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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Liver Transplant
Keywords: Everolimus
CertiroBell
Mycophenolate mofetil
Lead sponsor: Chong Kun Dang Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2020-07-15
Enrollment: 150
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Incidence of composite efficacy failure
timeFrame: until 24 weeks after taking medicine
Secondary outcomes:
measure: Incidence of biopsy-confirmed acute rejection
timeFrame: until 24weeks and 48weeks after taking medicine
measure: 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)
timeFrame: until 24weeks and 48weeks after taking medicine
measure: Incidence of composite efficacy failure
timeFrame: until 48weeks after taking medicine
measure: Survival rate of patients
timeFrame: until 24weeks and 48weeks after taking medicine
measure: Survival rate of transplanted organ
timeFrame: until 24weeks and 48weeks after taking medicine
measure: Incidence and recurrence rates of liver cancer
timeFrame: until 24weeks and 48weeks after taking medicine
measure: Incidence and recurrence rates of HCV infection
timeFrame: until 24weeks and 48weeks after taking medicine
measure: Incidence of CMV infection
timeFrame: until 24weeks and 48weeks after taking medicine
measure: variation of Serum creatinine, eGFR(estimated glomerular filtration rate) compared to the baseline
timeFrame: at 24 weeks and 48weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
Study officials:
affiliation: Severance Hospital
name: Soon Il Kim, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: