A Research Study Looking at How Safe Somapacitan is and How Well it Works in Children Who Need Help to Grow - REAL 9
第3相
実施中（募集終了）
NCT05723835
| 対象疾患 | SGA, Turner Syndrome, Noonan Syndrome, ISS |
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| 相 | 第3相 |
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| スポンサー | Novo Nordisk A/S |
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| ステータス | 実施中（募集終了） |
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| 参加者数 | 47 名 |
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| 介入（薬剤） | Somapacitan |
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| 開始日 | 2023年2月1日 |
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| 完了日 | 2024年6月7日 |
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| 結果公開日 | 2025年11月21日 |
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概要
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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BENITIONS で見る
ClinicalTrials.gov の原文を見る
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