A Research Study Looking at How Safe Somapacitan is and How Well it Works in Children Who Need Help to Grow - REAL 9
3期
进行中（已停止招募）
NCT05723835
| 适应症 | SGA, Turner Syndrome, Noonan Syndrome, ISS |
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| 分期 | 3期 |
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| 申办方 | Novo Nordisk A/S |
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| 状态 | 进行中（已停止招募） |
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| 受试者人数 | 47 人 |
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| 干预（药物） | Somapacitan |
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| 开始日期 | 2023年2月1日 |
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| 完成日期 | 2024年6月7日 |
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| 结果公布日 | 2025年11月21日 |
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摘要
The purpose of this study is to find out if somapacitan is safe and how well somapacitan works in children either born small for gestational age or with Turner syndrome, Noonan syndrome or idiopathic short stature. Somapacitan is a new growth hormone medicine for treatment of low level of growth hormone. The study will last for about 3 years. During the study, the participants will be treated with somapacitan once a week. Somapacitan can be injected anytime during the day. The study doctor or nurse will show how to inject somapacitan, so that the participant knows how to do it at home.
Number of Adverse Events (AEs) Reported in Children Born Small for Gestational Age- Weeks 0 to 26
From baseline (Week 0) to Week 26 · Events
| SGA_somapacitan (GH Treatment Naïve) | 4 Events |
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| SGA_somapacitan (Previously Treated With GH) | 10 Events |
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Number of Adverse Events Reported for Turner Syndrome (TS)- Weeks 0 to 26
From baseline (Week 0) to Week 26 · Events
| TS_somapacitan (GH Treatment Naïve) | 4 Events |
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| TS_somapacitan (Previously Treated With GH) | 18 Events |
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Number of Adverse Events Reported for Noonan Syndrome- Weeks 0 to 26
From baseline (Week 0) to Week 26 · Events
| NS_somapacitan (GH Treatment Naïve) | 13 Events |
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| NS_somapacitan (Previously Treated With GH) | 11 Events |
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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。