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临床试验/JPRN-jRCT2080222628
JPRN-jRCT2080222628已完成3 期

A Phase 3 Study of CS-8958 (Prophylaxis of Single Administration) - A randomized, double-blind, placebo-controlled study to evaluate the efficacy of single dose administration for the prevention of influenza virus infection

DAIICHI SANKYO CO., LTD.0 个研究点目标入组 803 人开始时间: 2014年10月16日最近更新:

试验速览

阶段
3 期
状态
已完成
入组人数
803

研究概览

简要总结

Single dose of inhaled CS-8958 40 mg was effective as post-exposure prophylaxis to prevent the development of influenza through household contacts, as was the inhalation of 20 mg of CS-8958 once daily for 2 days. Adverse events in CS-8958 40 mg single-dose group did not differ significantly from those in the CS-8958 20 mg once daily for 2 days administration group and placebo-group. No abnormal behaviors were observed, and there were no other major safety issues.

研究设计

研究类型
Interventional

入排标准

年龄范围
>= 10age old 至 ot applicable(—)
性别
All

入选标准

  • Household contact of a patient with influenza virus infection
  • Body temperature (axillary) at informed consent =< 36.9 degrees C
  • No influenza symptoms

排除标准

  • Persons who are unable to cohabit with an index patient
  • Persons who cannot start study treatment within 48 hours after the initial onset of any influenza symptom in the index patient
  • Persons receiving corticosteroids or immunosuppressants
  • Persons who have a history of hypersensitivity to a neuraminidase inhibitor

研究者

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