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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
150
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.
Up to 1.5g BID(total 3g daily), PO
Severance Hospital
Seoul, South Korea
Incidence of composite efficacy failure
composite efficacy failure include biopsy-confirmed acute rejection, graft loss, death, or follow-up failure
Time frame: until 24 weeks after taking medicine
Incidence of biopsy-confirmed acute rejection
acute rejection confirmed by result of biopsy(over 4 points of RAI score)
Time frame: 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)
details of acute rejection confirmed by result of biopsy(over 4 points of RAI score)
Time frame: until 24weeks and 48weeks after taking medicine
Incidence of composite efficacy failure
composite efficacy failure include biopsy-confirmed acute rejection, graft loss, death, or follow-up failure
Time frame: until 48weeks after taking medicine
Survival rate of patients
Survival rate of patients
Time frame: until 24weeks and 48weeks after taking medicine
Survival rate of transplanted organ
Survival rate of transplanted organ
Time frame: until 24weeks and 48weeks after taking medicine
Incidence and recurrence rates of liver cancer
Incidence and recurrence rates of liver cancer
Time frame: until 24weeks and 48weeks after taking medicine
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Incidence and recurrence rates of HCV infection
Incidence and recurrence rates of HCV infection
Time frame: until 24weeks and 48weeks after taking medicine
Incidence of CMV infection
Incidence of CMV infection
Time frame: until 24weeks and 48weeks after taking medicine
variation of Serum creatinine, eGFR(estimated glomerular filtration rate) compared to the baseline
eGFR using MDRD(Modification of Diet in Renal Disease) method
Time frame: at 24 weeks and 48weeks