Study of Obeldesivir to Treat Children With Respiratory Syncytial Virus (RSV) Infection
Фаза 2
Прекращено
NCT06784973
| Заболевание | RSV Infection |
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| Фаза | Фаза 2 |
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| Спонсор | Gilead Sciences |
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| Статус | Прекращено |
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| Участники | 4 участн. |
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| Вмешательство | Obeldesivir, Obeldesivir Placebo |
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| Дата начала | 5.03.2025 |
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| Дата завершения | 16.04.2025 |
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| Публикация результатов | 8.06.2026 |
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Кратко
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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