JPRN-jRCT2031210664招募中3 期
A Phase 3, Multicenter, Randomized, Partially Blinded, Palivizumab-Controlled Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of MK-1654 in Infants and Children at Increased Risk for Severe RSV Disease
Tanaka Yoshiyuki0 个研究点目标入组 1,000 人开始时间: 2022年3月12日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 1,000
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
- ot applicable 至 <= 1age old（—）
- 性别
- All
入选标准
- •Participants at increased risk for severe RSV infection recommended to receive palivizumab in accordance with national or local guidelines or professional society recommendations.
- •- Is available to complete the follow-up period.
排除标准
- •- Requires mechanical ventilation at time of enrollment.
- •- Has a life expectancy <6 months.
- •- Has known hepatic or renal dysfunction, or chronic seizure disorder.
- •- Is hospitalized at the time of randomization unless discharge is expected within 7 days after randomization.
- •- Has severe immunodeficiency or is severely immunocompromised.
- •- Has known hypersensitivity to any component of MK-1654 or palivizumab.
研究者
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