Liver Transplant
Conditions
Keywords
Everolimus, CertiroBell, Mycophenolate mofetil
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.
Interventions
DRUGEverolimus 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.
DRUGMycophenolate mofetil Tab./Cap.
Up to 1.5g BID(total 3g daily), PO
Sponsors
Chong Kun Dang Pharmaceutical
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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 |
| 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 |
| Incidence of CMV infection | until 24weeks and 48weeks after taking medicine | Incidence of CMV 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 |
Countries
South Korea
Contacts
STUDY_CHAIRDong Jin Joo, M.D., Ph.D.
Severance Hospital
Outcome results
None listed