Multi-center, Open-label, Randomized Controlled Phase 4 Study to Evaluate the Efficacy and Safety of CertiroBell® Compared With Mycophenolate Mofetil in Primary Living Donor Liver Transplant Recipients.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Incidence of composite efficacy failure
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •* 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)
排除标准
- •[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
研究组 & 干预措施
Mycophenolate mofetil Tablet/Capsule
De novo liver transplant recipients will be randomized after liver transplant operation.
干预措施: Mycophenolate mofetil Tab./Cap. (Drug)
CertiroBell Tablet
De novo liver transplant recipients will be randomized after liver transplant operation.
干预措施: Everolimus Tab. (Drug)
结局指标
主要结局
Incidence of composite efficacy failure
时间窗: until 24 weeks after taking medicine
composite efficacy failure include biopsy-confirmed acute rejection, graft loss, death, or follow-up failure
次要结局
- 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)
- Incidence of composite efficacy failure(until 48weeks after taking medicine)
- Incidence of biopsy-confirmed acute rejection(until 24weeks and 48weeks after taking medicine)
- Survival rate of patients(until 24weeks and 48weeks after taking medicine)
- Survival rate of transplanted organ(until 24weeks and 48weeks after taking medicine)
- Incidence and recurrence rates of liver cancer(until 24weeks and 48weeks after taking medicine)
- Incidence and recurrence rates of HCV infection(until 24weeks and 48weeks after taking medicine)
- variation of Serum creatinine, eGFR(estimated glomerular filtration rate) compared to the baseline(at 24 weeks and 48weeks)
- Incidence of CMV infection(until 24weeks and 48weeks after taking medicine)