Study of Obeldesivir to Treat Children With Respiratory Syncytial Virus (RSV) Infection
2期
提前终止
NCT06784973
| 适应症 | RSV Infection |
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| 分期 | 2期 |
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| 申办方 | Gilead Sciences |
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| 状态 | 提前终止 |
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| 受试者人数 | 4 人 |
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| 干预（药物） | Obeldesivir, Obeldesivir Placebo |
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| 开始日期 | 2025年3月5日 |
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| 完成日期 | 2025年4月16日 |
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| 结果公布日 | 2026年6月8日 |
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摘要
The goal of this clinical study is to check if obeldesivir (ODV; GS-5245) is safe and well-tolerated by children with respiratory syncytial virus (RSV) infection. It will also look at how well ODV helps reduce the time it takes for children to feel better and for their RSV symptoms to improve. The primary objectives of this study are: a) to evaluate the safety and tolerability of ODV in pediatric participants with RSV infection; b) To evaluate the efficacy of ODV on time to alleviation of targeted RSV symptoms in pediatric participants with RSV infection.
Percentage of Participants Who Experienced Treatment-Emergent Adverse Events (TEAEs) by Day 28
Up to Day 28 · percentage of participants
| Cohort 1: Part A (Group 2) - Obeldesivir (ODV) | 0 percentage of participants |
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| Cohort 1: Part A (Group 3) - ODV | 100.0 percentage of participants |
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| Cohort 1: Part A (Group 3) - Placebo | 100.0 percentage of participants |
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Percentage of Participants Who Experienced Grade 3 or 4 Treatment-Emergent Laboratory Abnormalities by Day 28
Up to Day 28 · percentage of participants
| Cohort 1: Part A (Group 2) - Obeldesivir (ODV) | 0 percentage of participants |
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| Cohort 1: Part A (Group 3) - ODV | 0 percentage of participants |
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| Cohort 1: Part A (Group 3) - Placebo | 100.0 percentage of participants |
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Time to Alleviation of Targeted Respiratory Syncytial Virus (RSV) Symptoms by Day 28
Up to Day 28 · days
| Cohort 1: Part A (Group 2) - Obeldesivir (ODV) | 5.4 days |
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| Cohort 1: Part A (Group 3) - ODV | NA days |
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本页整理自 ClinicalTrials.gov 的公开数据，不构成医疗建议，也不构成投资建议。请务必咨询专业医师。