A Research Study Looking at How Safe Somapacitan is and How Well it Works in Children Who Need Help to Grow - REAL 9
3상
진행 중(모집 완료)
NCT05723835
| 대상 질환 | SGA, Turner Syndrome, Noonan Syndrome, ISS |
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| 임상 단계 | 3상 |
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| 스폰서 | Novo Nordisk A/S |
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| 상태 | 진행 중(모집 완료) |
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| 참여자 수 | 47 명 |
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| 중재(약물) | Somapacitan |
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| 시작일 | 2023년 2월 1일 |
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| 완료일 | 2024년 6월 7일 |
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| 결과 공개일 | 2025년 11월 21일 |
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요약
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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BENITIONS에서 보기
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