EUCTR2016-001651-49-HR进行中（未招募）1 期
A randomized, double-blind, placebo-controlled, multicenter dose ranging study of ALX-0171 in infants and young children hospitalized for respiratory syncytial virus lower respiratory tract infection - Respire
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Ablynx NV
- 入组人数
- 180
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Subject is a male or female infant or young child aged 28 days to < 2 years with gestational age = 33 weeks at screening.
- •- Subject is otherwise healthy, but is hospitalized for and clinically diagnosed with RSV lower respiratory tract infection.
- •- Subject has a positive RSV diagnostic test at screening.
- •- Subject is expected to have to stay in the hospital for at least 24 hours.
- •- Parent(s)/legal guardian(s) provide written informed consent in accordance with locally approved consent process at screening.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 180
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Subject is known to have significant comorbidities
- •- Subject is known to be HIV-positive. If the subject is < 6 months of age, a known HIV-positivity of the mother is also exclusionary.
- •- Subject is known to be immunocompromised.
- •- Subject has or is suspected to have an active, clinically relevant concurrent infection
- •- Subject is critically ill and/or is expected to require invasive mechanical ventilation
- •- Subject is currently participating in any other study with investigational drug or has received an investigational drug within 4 weeks or 5 half-lives of the concerned drug (whichever is longer) prior to screening
- •- Subject was previously enrolled in a clinical study of ALX-0171
研究者
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