NCT02075242Unknown4 期
Open Label, Multi-center, Randomized Study to Compare of Tacrolimus and Steroids in Combination With Mycophenolate Mofetil or Without Mycophenolate Mofetil in Liver Transplantation With Hepatitis B Virus(HBsAg) Positive
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 入组人数
- 170
- 试验地点
- 1
- 主要终点
- rejection
研究概览
简要总结
Study to Compare the Safety and Efficacy of Tacrolimus and Steroids in Combination With Mycophenolate Mofetil or Without Mycophenolate Mofetil in Liver Transplantation with Hepatitis B Virus(HBsAg) Positive
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or women at the age of 20 to 65
- •Patients who will have primary Liver Transplantation becaused of Chronic Hepatitis B of HbsAg positive
- •Having confirmed a result of HBsAg positive patients within 6 months prior to Screening point.
- •Patients who will have Liver Transplantation from ABO-compatible or proper living donor ⑤ Patients who will receive investigational products for the entire period of clinical trial.
- •Patients who have signed the informed consent after understanding of clinical trial's purpose and risk.
- •For women of childbearing potential, pregnancy test negative from urine or blood AND women who agree to contraception for the entire period of clinical trial.
排除标准
- •Recipients who had Liver Transplantation OR who had or will have other organ transplantation
- •Recipients who other organ transplantation in addition to liver at once.
- •Recipients who will have Auxiliary Partial Orthotopic Liver Transplantation.
- •Recipients who use a Bioartificial liver prior to Transplantation
- •Cr > 2.0mg/dl at screening test
- •Patients who had malignant tumor within the past 5 years OR have malignant tumor(except, successfully treated Skin's non-metastatic basal cell carcinoma, squamous cell carcinoma or primary hepatocellular carcinoma )
- •Recipients had hepatocellular carcinoma whick is out of Milan criteria
- •WBC<1,500/mm3 or ANC<900/mm3 or PLT<30,000/mm3 at Screening
- •Investigator judge that a patient is not proper to enroll this study due to Severe digestive disorder at Screening
- •Patients who have severe systemic infection (But the liver transplantation is excepted that performed after the infection is completely lost or well-controlled)
- •⑪ Recipients who had Liver transplantation from HBsAg positive donor
- •⑫ Recipients or Donors are HIV, HCV Positive
- •⑬ Patients who need to systemc chemotherapy or immunosuppressive therapy prior to transplantation or took immunosuppressants within 30 days prior to liver transplantation(except, investigational products per protocol and corticosteroid)
- •⑭ Patients who have hypersensitivity to mycophenolate, mycophenolate acid, ingredient of investigational products, tacrolimus , Macrolide antibiotic and Steroids
- •⑮ Patients who had been received or have been received other investigational products within 28 days prior to screening 16 Pregnant women and lactating women 17 Substance abuse patient, mentally defective person or patients who is not possible to participate in clinical trial by law 18 Investigator judge that a patient have communication disorder 19 Patients are not capable of visiting accor.ding to study visit schedule 20 Investigator judge that a patient is not proper to enroll this study, et cetera
研究组 & 干预措施
tacrolimus
Active Comparator
Control group: Tacrolimus + Corticosteroid (dual oral therapy)
干预措施: Tacrolimus (Drug)
Mycophenolate Mofetil
Experimental
Tacrolimus + Mycophenolate Mofetil+Corticosteroid (triple oral therapy)
干预措施: Mycophenolate Mofetil (Drug)
Mycophenolate Mofetil
Experimental
Tacrolimus + Mycophenolate Mofetil+Corticosteroid (triple oral therapy)
干预措施: Tacrolimus (Drug)
结局指标
主要结局
rejection
时间窗: within 6months
• Incidence rate has been confirmed acute cellular rejection(RAI 4 and over) from liver biopsy
次要结局
- rate of HBV(within 6 months)
- Graft survival rate(within 6 months)
研究者
Sung-Gyu Lee
Professor, Department of surgery, Asan medical center
Asan Medical Center
研究点 (1)
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