NCT00238901已完成3 期
Efficacy and Safety of Basiliximab in HCV+ Patients Undergoing Liver Transplantation, as Compared With Steroids, Both Given in Combination With Cyclosporine and Mycophenolate Mofetil (MMF)
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 194
- 主要终点
- 12-month cumulative incidence of post-surgical graft loss and death
研究概览
简要总结
The natural history of HCV infection in liver transplant recipients may be accelerated when compared to that in patients with normal immune systems.
The objective of this trial is to assess the efficacy and safety of basiliximab, in combination with cyclosporin and MMF on the success rate of liver transplants for HCV related cirrhosis, in comparison with standard steroid treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing first cadaver liver transplant Patients receiving an AB0 identical or compatible graft HCV+ patients (serology test within the last 12 months)
排除标准
- •Antiretroviral prophylactic treatment post-transplant Serological markers positive for Hepatitis B surface Antigen and Human Immunodeficiency Virus Recipients of a split liver transplant Other protocol-defined inclusion/exclusion criteria applied
结局指标
主要结局
12-month cumulative incidence of post-surgical graft loss and death
次要结局
- hepatitis C recurrence (see definition 3.5.2) at 6 and 12 months after transplant surgery.
- treated and biopsy proven acute rejection at 6 and 12 months after transplant surgery.
- graft survival and patient survival after treatment with either Simulect or steroids at 6 and 12 months.
- viral load (HCV-RNA) after treatment with Simulect or steroids at Baseline, Month 1 and 3 post transplantation.
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