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

Recruitment & 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

Exclusion Criteria

Not provided

Study & Design

Arm && Interventions

Group	Intervention	Description
CertiroBell Tablet	Everolimus Tab.	De novo liver transplant recipients will be randomized after liver transplant operation.
Mycophenolate mofetil Tablet/Capsule	Mycophenolate mofetil Tab./Cap.	De novo liver transplant recipients will be randomized after liver transplant operation.

Primary Outcome Measures

Name	Time	Method
Incidence of composite efficacy failure	until 24 weeks after taking medicine	composite efficacy failure include biopsy-confirmed acute rejection, graft loss, death, or follow-up failure

Secondary Outcome Measures

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

Recruitment & Eligibility