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临床试验/NCT00036179
NCT00036179已完成2 期

An Open-Label, Non-Comparative Study of FK463 in the Treatment of Candidemia or Invasive Candidiasis

Astellas Pharma Inc23 个研究点 分布在 8 个国家目标入组 75 人开始时间: 1999年2月27日最近更新:
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适应症
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
75
试验地点
23
研究概览研究设计入排标准研究者研究点记录与标识符相似试验

研究概览

简要总结

The purpose of the study is to evaluate the safety and efficacy of FK463 in the treatment of patients with confirmed candidemia or invasive candidiasis.

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 Candidemia or invasive candidiasis documented by typical clinical signs and symptoms and confirmed by fungal culture or histologic confirmation

排除标准

  • •Has abnormal liver test parameters, e.g., AST or ALT > 10 times upper limit of normal
  • •Has life expectancy judged to be less than 5 days
  • •De novo patients who have received a systemic antifungal agent for the treatment of this episode of candidemia or invasive candidiasis for more than 48 hours prior to the first dose of FK463; or efficacy failure patients who have received =< 5 days of prior systemic antifungal therapy for the treatment of this episode of candidemia or invasive candidiasis
  • •Require treatment with topical or systemic antifungal agents for conditions other than candidemia or invasive candidiasis

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (23)

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Study of FK463 in the Treatment of Candidemia or... | 临床试验