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临床试验/PER-036-03
PER-036-03已完成1 期

COMPARATIVE STUDY OF PHASE 3, RANDOMIZED, DOUBLE BLIND MICAFUNGIN (FK463) VERSUS FLUCONAZOL FOR THE TREATMENT OF CANDIDIASIS ESOFAGITIS

FUJISAWA HEALTH CARE INC,0 个研究点目标入组 0 人开始时间: 2003年7月14日最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
发起方

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

年龄范围
0 至 0(—)

入选标准

  • Diagnosis of esophageal candidiasis confirmed by endoscopy
  • Negative pregnancy test in females of childbearing potential

排除标准

  • Pregnant or nursing
  • Evidence of liver disease
  • Presence of another active opportunistic fungal infection and/or receiving acute systemic therapy for an opportunistic fungal infection
  • Concomitant esophagitis caused by herpes simplex virus or cytomegalovirus
  • Receipt of an oral or topical antifungal agent within 48 hours or a systemic agent within 72 hours of first dose of study drug
  • Non-responsive to therapy in any prior systemic antifungal clinical trail
  • History of > 2 episodes of esophageal candidiasis requiring systemic antifungal therapy
  • History of anaphylaxis attributed to azole compounds or echinocandin class of antifungals

研究者

发起方
FUJISAWA HEALTH CARE INC,

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