Liver Transplant
Conditions
Keywords
Everolimus, CertiroBell, Tacrolimus
Brief summary
To evaluate the efficacy and safety of CertiroBell® tablet plus tacrolimus
Detailed description
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.
Interventions
DRUGEverolimus
\- 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.
Sponsors
Chong Kun Dang Pharmaceutical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients who had liver transplantation from living donor and had passed over 3 months since operation. 2. Over 20 years old 3. Patients who are being treated with Tacrolimus at screening visit 4. Patients who agreed to written informed consent
Exclusion criteria
1. Patients who had received non-liver organs before liver transplantation or had received other organs while receiving liver. 2. Patients who had auxiliary partial orthotopic liver transplantation or had bioartifical liver 3. Patients who have been diagnosed with acute rejection within 6 months and have been treated 4. Patients who had hepatic artery complication such as hepatic artery thrombosis within recent 6 months 5. Patients who have been diagnosed with malignant tumor within 5 years(however, the following will be excepted) * fully recovered from skin cancer(squamous cell/basal cell carcinoma or thyroid cancer) * haptocellular carcinoma without main vessel invasion 6. Patients with severe systemic infection 7. Patients who are difficult to communicate due to mental disorder 8. Patients who are in treatment for hapatitis, or are over 3 times higher than upper normal limit in liver function test(T-bilirubin, AST, ALT) or over 5 times higher than normal limit of ALP 9. Patients who are(at screening visit) * WBC\<1,500/mm\^3 * PLT\<30,000/mm\^3 * over 1.0 in Protein/creatinine ratio(UA test) * eGFR\<30mL/min/1.73m\^2(MDRD) * Total Cholesterol\>350mg/dL or Triglycerides\>500mg/dL 10. Patients taking HCV(hapatitis C virus) therapeutic drug or anti-HCV positive patients who have positive result in HCV RNA test at screening visit 11. Patients who had plasmapheresis within 1 week 12. Those who are pregnant, nursing, or are not practicing contraception with appropriate method 13. Patients who had plasmapheresis within 3 months 14. if participated in other trail within 4 weeks(28 days) 15. 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 |
|---|---|---|
| Pathological result, time of occurrence, treatment method and treatment result of acute rejection confirmed by biopsy(over 4 points of RAI score) | until 24 weeks after taking medicine | details of acute rejection confiremd by result of biopsy(over 4 points of RAI score) |
| Survival rate of patients | until 24 weeks after taking medicine | Survival rate of patients |
| Survival rate of transplanted organ | until 24 weeks after taking medicine | Survival rate of transplanted organ |
| Incidence of biopsy-confirmed acute rejection | until 24 weeks after taking medicine | acute rejection confirmed by result of biopsy(over 4 points of RAI score) |
| Recurrence rate of liver cancer | until 24 weeks after taking medicine | Recurrence rate of liver cancer |
| Incidence rate of CMV infection | until 24 weeks after taking medicine | Incidence rate of CMV infection |
| Variation of serum creatinine, eGFR(estimated glomerular filtration rate) compared to baseline using MDRD(Modification of Diet in Renal Disease) | until 24 weeks after taking medicine | eGRF using MDRD(Modification of Diet in Renal Disease) method |
| Incidence rate of liver cancer | until 24 weeks after taking medicine | Incidence rate of liver cancer |
Countries
South Korea
Contacts
Primary ContactKyung-Suk Suh, M.D., Ph.D.
Outcome results
None listed