NCT00036166已完成2 期
An Open-Label, Non-Comparative Study of FK463 for the Treatment of Invasive Aspergillosis
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 326
- 试验地点
- 23
研究概览
简要总结
The purpose of the study is to evaluate the safety and efficacy of FK463 in patients with proven or probable invasive infections due to Aspergillus species.
详细描述
This will be an open-label, non-comparative study of intravenous FK463. Enrollment will include at least 100 patients evaluable for efficacy.
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
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Has proven or probable systemic infection with Aspergillus species
排除标准
- •Has abnormal liver test parameters, e.g., AST or ALT > 10 times upper limit of normal
- •Has bronchopulmonary aspergillosis, aspergillomas, sinus aspergillosis or external otitis but does not have histologic evidence of tissue invasion
- •Has life-expectancy judged to be less than 5 days
研究者
研究点 (23)
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