NCT00295607已完成2 期
Comparing Efficacy and Safety of Tacrolimus With Steroids or Monoclonal Anti-IL2R Antibody in HCV Positive in Liver Transplantation
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 138
- 主要终点
- Viral load of HCV at 12 months post transplantation
研究概览
简要总结
This is an exploratory study to evaluate the impact of eliminating steroid administration upon viral HCV load at 12 months measured by quantitative serum HCV-RNA determination in patients transplanted for HCV cirrhosis.
详细描述
A comparison will be made between two regimens which both include tacrolimus, one utilizing standard steroid administration and the second with daclizumab (MAB) avoiding steroids for both prophylactic administration and anti-rejection 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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients 18 to 65 years of age who will undergo primary orthotopic liver or split liver allograft transplantation for HCV-cirrhosis are eligible for the study.
- •Patients receiving a cadaveric liver transplant with compatible ABO blood type can be included.
排除标准
- •Recipient of multi-organ transplant
- •Recipient of an auxiliary graft
- •Patient is receiving ABO incompatible graft
- •Patients requiring immunosuppressive treatment
- •Patients requiring ongoing corticosteroid therapy.
- •Patient has significant, uncontrolled concomitant infections and/or severe diarrhoea, vomiting, active upper gastro-intestinal tract malabsorption or active peptic ulcer.
- •Patient or donor is known to be HIV positive.
- •Patient is allergic or intolerant to study medication
- •Patient is pregnant or breast-feeding.
- •Patient has been previously enrolled in this study
研究组 & 干预措施
1
Active Comparator
干预措施: Tacrolimus (Drug)
1
Active Comparator
干预措施: steroids, monoclonal anti-IL2R antibody (Drug)
2
Experimental
干预措施: Tacrolimus (Drug)
结局指标
主要结局
Viral load of HCV at 12 months post transplantation
时间窗: 12 months
次要结局
- Biopsy-proven acute rejection(12 months)
- Acute rejection(12 months)
- Patient and graft survival(12 months)
- Incidence of adverse events(12 months)
研究者
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