JPRN-jRCT2080224119已完成3 期
A phase 3 randomized, double-blind, placebo-controlled study to confirm the efficacy of a single dose of baloxavir marboxil in the prevention of influenza virus infection
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 752
研究概览
简要总结
The efficacy of baloxavir marboxil was demonstrated compared with placebo in the prevention of influenza virus infection in subjects who were household members of influenza-infected patients. A single oral dose of baloxavir marboxil for the prevention of influenza virus infection was well tolerated.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- ot applicable 至 ot applicable(—)
- 性别
- All
入选标准
- •Subjects who had lived with the patients with influenza virus infection for 48 hours or more prior to informed consent.
- •-Subjects who are judged not to have influenza virus infection by the investigator.
排除标准
- •-Subjects who are unable to live with the index patient from Screening until Day 10.
- •-Subjects who have any underlying diseases requiring systemic (oral or injection), or nasal treatment of antipyretics/analgesics, corticosteroids, or immunosuppressive agents.
研究者
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