To evaluate the efficacy and safety of CertiroBell® tablet plus tacrolimus
This study is multi-center, single arm, open-label, phase 4 study to evaluate the efficacy and safety of CertiroBell® tablet plus tacrolimus in primary living donor liver transplant recipients.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
112
\- Oral intake, BID - After first dose 1mg(total 2mg daily), check the blood concentration of everolimus at each visit and adjust the dose to achieve the blood concentration maintaining at 3\~8mg/mL.
Seoul National University Hosipital
Seoul, South Korea
RECRUITINGIncidence 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 24 weeks after taking medicine
Pathological result, time of occurrence, treatment method and treatment result of acute rejection confirmed by biopsy(over 4 points of RAI score)
details of acute rejection confiremd by result of biopsy(over 4 points of RAI score)
Time frame: until 24 weeks after taking medicine
Survival rate of patients
Survival rate of patients
Time frame: until 24 weeks after taking medicine
Survival rate of transplanted organ
Survival rate of transplanted organ
Time frame: until 24 weeks after taking medicine
Incidence rate of liver cancer
Incidence rate of liver cancer
Time frame: until 24 weeks after taking medicine
Recurrence rate of liver cancer
Recurrence rate of liver cancer
Time frame: until 24 weeks after taking medicine
Incidence rate of CMV infection
Incidence rate of CMV infection
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Time frame: until 24 weeks after taking medicine
Variation of serum creatinine, eGFR(estimated glomerular filtration rate) compared to baseline using MDRD(Modification of Diet in Renal Disease)
eGRF using MDRD(Modification of Diet in Renal Disease) method
Time frame: until 24 weeks after taking medicine