JPRN-jRCT2080224512已完成3 期
An Open-label Study to Assess the Safety, Tolerability, Pharmacokinetics, and Efficacy of Baloxavir Marboxil 2% Granules after Administration of a Single Dose to Otherwise Healthy Pediatric Patients with Influenza
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 45
研究概览
简要总结
S-033188 2% granules were considered to be well tolerated and effective in pediatric patients with influenza virus infection who weighed less than 20 kg at higher doses than those administered in the previous studies in Japanese pediatric patients.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- ot applicable 至 <= 11age old（—）
- 性别
- All
入选标准
- •Patients confirmed with influenza virus infection and within 48 hours from onset.
- •- Patients whose body weight is less than 20 kg.
排除标准
- •-Patients with severe symptoms of influenza virus infection requiring inpatient treatment.
- •- Patients with high risk factors.
- •- Patients with concurrent infections requiring systemic antimicrobial and/or antiviral therapy.
研究者
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