NCT00469131已完成3 期
Randomized Comparative Study on Effects of Immunosuppression on HCV Recurrence After Living Donor Liver Transplantation - Comparison Between Tacrolimus + MMF and Tacrolimus + Steroid
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan1 个研究点 分布在 1 个国家目标入组 79 人开始时间: 2003年9月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 79
- 试验地点
- 1
- 主要终点
- Event-free survival time at the end of first year after living liver transplantation.
研究概览
简要总结
The aim of this study is to compare immunosuppression protocol of tacrolimus + MMF with that of tacrolimus + steroid for preventing recurrence of hepatitis C after living donor liver transplantation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Recipient of living donor liver transplantation for HCV-related cirrhosis
排除标准
- •ABO blood type incompatible transplant case
- •Renal dysfunction (serum creatinine >2.0 mg/dL)
- •WBC < 1,000/mm3
- •Hemoglobin < 8 g/dL
- •Platelet <30,000 /mm3
研究组 & 干预措施
1 Drug:
Active Comparator
tacrolimus + steroid
干预措施: tacrolimus + steroid (Drug)
2 Drug:
Active Comparator
tacrolimus + mycophenolate mofetil
干预措施: tacrolimus + mycophenolate mofetil (Drug)
结局指标
主要结局
Event-free survival time at the end of first year after living liver transplantation.
时间窗: 1 year
次要结局
- HCV-RNA value, patient survival, recurrence-free survival, rate of interferon therapy induction, rate of steroid pulse for rejection, chronic rejection(1 year)
研究者
研究点 (1)
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