Study of Obeldesivir to Treat Children With Respiratory Syncytial Virus (RSV) Infection
第2相
早期終了
NCT06784973
| 対象疾患 | RSV Infection |
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| 相 | 第2相 |
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| スポンサー | Gilead Sciences |
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| ステータス | 早期終了 |
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| 参加者数 | 4 名 |
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| 介入（薬剤） | Obeldesivir, Obeldesivir Placebo |
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| 開始日 | 2025年3月5日 |
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| 完了日 | 2025年4月16日 |
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| 結果公開日 | 2026年6月8日 |
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概要
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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BENITIONS で見る
ClinicalTrials.gov の原文を見る
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