NCT00047827终止2 期
A Phase 2, Open-Label, Non-Comparative Trial of Micafungin (FK463) in Combination With Liposomal Amphotericin B (AmBisome) as First-Line Therapy in the Treatment of Invasive Aspergillosis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 2
- 主要终点
- Incidence of treatment response defined as complete or partial response
研究概览
简要总结
The purpose of this study is to evaluate the safety and effectiveness of micafungin in combination with AmBisome as first-line therapy in the treatment of invasive aspergillosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
1
Experimental
干预措施: Micafungin (Drug)
1
Experimental
干预措施: Liposomal Amphotericin B (Drug)
结局指标
主要结局
Incidence of treatment response defined as complete or partial response
时间窗: Day 28, end of combined therapy and Day 84
次要结局
- Radiological Response(Day 28, end of combined therapy and Day 84)
- Mycological Response(Day 28, end of combined therapy and Day 84)
- Survival at Day 84(Day 84)
- Clinical Response(Day 28, end of combined therapy and Day 84)
研究者
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