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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CertiroBell Tablet | Experimental | De novo liver transplant recipients will be randomized after liver transplant operation. |
|
| Mycophenolate mofetil Tablet/Capsule | Active Comparator | De novo liver transplant recipients will be randomized after liver transplant operation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Everolimus Tab. | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of composite efficacy failure | composite efficacy failure include biopsy-confirmed acute rejection, graft loss, death, or follow-up failure | until 24 weeks after taking medicine |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of biopsy-confirmed acute rejection | acute rejection confirmed by result of biopsy(over 4 points of RAI score) | 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) |
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* Inclusion Criteria:
[Time of screening]
[Time of randomization] - Patients who have transplanted liver within 4 weeks(25 days to 35 days)
* Exclusion Criteria
[Time of screening]
[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
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
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| Name | Affiliation | Role |
|---|---|---|
| Dong Jin Joo, M.D., Ph.D. | Severance Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Severance Hospital | Seoul | South Korea |
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| ID | Term |
|---|---|
| D000068338 | Everolimus |
| ID | Term |
|---|---|
| D020123 | Sirolimus |
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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|
| Mycophenolate mofetil Tab./Cap. | Drug | Up to 1.5g BID(total 3g daily), PO |
|
details of acute rejection confirmed by result of biopsy(over 4 points of RAI score) |
| 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 | until 48weeks after taking medicine |
| Survival rate of patients | Survival rate of patients | until 24weeks and 48weeks after taking medicine |
| Survival rate of transplanted organ | Survival rate of transplanted organ | until 24weeks and 48weeks after taking medicine |
| Incidence and recurrence rates of liver cancer | Incidence and recurrence rates of liver cancer | until 24weeks and 48weeks after taking medicine |
| Incidence and recurrence rates of HCV infection | Incidence and recurrence rates of HCV infection | until 24weeks and 48weeks after taking medicine |
| Incidence of CMV infection | Incidence of CMV infection | 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 | at 24 weeks and 48weeks |