jRCT2031240735招募中不适用
A Phase 2, Randomized, Multicenter, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of Obeldesivir in Participants From Birth to < 5 Years of Age With Respiratory Syncytial Virus (RSV) Infection
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 130
- 主要终点
- Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Double Blind
入排标准
- 年龄范围
- No limit 至 5age old not（—）
- 性别
- All
入选标准
- •Participants assigned male or female at birth, from birth to < 5 years of age who meet one of the following criteria, where permitted according to local law and approved nationally and by relevant institutional review board or independent ethics committee:
- •Cohort 1: Infants and children from 4 weeks postnatal age, weighing >= 1.5 kg to < 40 kg
- •Cohort 2: Neonates, either born at term or preterm, weighing >= 1.5 kg to < 6 kg
- •RSV infection diagnosis <= 3 days prior to randomization.
- •Negative test for influenza A/B, and SARS-CoV-2 infection <= 7 days prior to randomization.
- •Onset of RSV signs or symptoms <= 3 days prior to randomization.
- •Presence of at least 1 sign or symptom of RSV infection at screening and at randomization.
排除标准
- •Currently requiring or expected to require hospitalization for RSV infection within 48 hours after randomization.
- •Documented previous infection and/or hospitalization for RSV during the current respiratory virus season.
- •Diagnosed with acute concurrent active systemic infections requiring treatment with systemic antiviral, antibacterial, antifungal, or antimycobacterial therapy, or with any documented respiratory viral infection (other than RSV), <= 7 days prior to randomization.
- •History of asthma or recurrent wheezing.
- •Neuromuscular disease that affects swallowing.
- •Cystic fibrosis.
- •Participants who are immunocompromised.
- •Alanine aminotransferase >= 5 times upper limit of normal (ULN).
- •Abnormal renal function.
- •Concurrent or previous treatment with other agents with actual or possible direct antiviral activity against RSV, received within 28 days or within 5 half-lives, whichever is longer, prior to randomization.
- •Received palivizumab within 100 days, or nirsevimab within 1 year, or other RSV specific monoclonal antibody within 5 half-lives of the antibody, prior to randomization.
- •Participant whose mother received RSV vaccination during pregnancy and who is < 1 year old prior to randomization.
- •Note: Other protocol defined Inclusion/Exclusion criteria may apply.
结局指标
主要结局
Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
时间窗: Through Day 28
Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
Percentage of Participants Experiencing Grade 3 or 4 Treatment-emergent laboratory abnormalities
时间窗: by Day 28
Percentage of Participants Experiencing Grade 3 or 4 Treatment-emergent laboratory abnormalities
Time to Alleviation of Targeted RSV Symptoms
时间窗: by Day 28
Time to Alleviation of Targeted RSV Symptoms
次要结局
- AUCtau of ODV metabolite, GS-441524
- Cmax of ODV metabolite, GS-441524
- Ctrough of ODV metabolite, GS-441524
- Change From Baseline in RSV Nasal Swab Viral Load(Day 5)
- Time to Sustained Alleviation of Targeted RSV Symptoms(Day 28)
- Time to Resolution of Targeted RSV Symptoms(Day 28)
- Palatability and Acceptability Scores of Age-specific Formulation(Days 1 and 5)
研究者
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