Study of Obeldesivir to Treat Children With Respiratory Syncytial Virus (RSV) Infection
2상
조기 종료
NCT06784973
| 대상 질환 | RSV Infection |
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| 임상 단계 | 2상 |
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| 스폰서 | Gilead Sciences |
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| 상태 | 조기 종료 |
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| 참여자 수 | 4 명 |
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| 중재(약물) | Obeldesivir, Obeldesivir Placebo |
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| 시작일 | 2025년 3월 5일 |
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| 완료일 | 2025년 4월 16일 |
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| 결과 공개일 | 2026년 6월 8일 |
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요약
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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BENITIONS에서 보기
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