A Research Study in Children With a Low Level of Hormone to Grow. Treatment is Somapacitan Once a Week Compared to Norditropin® Once a Day (REAL4)
3상
완료
NCT03811535
| 대상 질환 | Growth Hormone Deficiency in Children |
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| 임상 단계 | 3상 |
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| 스폰서 | Novo Nordisk A/S |
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| 상태 | 완료 |
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| 참여자 수 | 200 명 |
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| 중재(약물) | Somapacitan, Norditropin® |
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| 시작일 | 2019년 5월 20일 |
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| 완료일 | 2021년 11월 10일 |
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| 결과 공개일 | 2023년 8월 4일 |
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요약
The study compares 2 medicines for children who do not have enough hormone to grow: somapacitan given once a week (a new medicine) and Norditropin® given once a day (the medicine doctors can already prescribe). Researchers will test to see how well somapacitan works. The study will also test if somapacitan is safe. Participants will either get somapacitan or Norditropin® - which treatment participants get, is decided by chance. Both participants and the study doctor will know which treatment participants get. The study will last for 4 years. Participants will attend 19 clinic visits and have 1 phone call with the study doctor.
Height Velocity: In-trial Observation Period
From baseline (week 0) to visit 7 (week 52) · centimeters per year (cm/year)
| Norditropin | 11.8 ± 2.9 centimeters per year (cm/year) |
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| Somapacitan | 11.2 ± 2.5 centimeters per year (cm/year) |
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| Treatment difference | -0.5 (95% CI -1.1–0.2) |
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Height Velocity: On-treatment Observation Period
From baseline (week 0) to visit 7 (week 52) · cm/year
| Norditropin | 11.8 ± 2.9 cm/year |
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| Somapacitan | 11.2 ± 2.5 cm/year |
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| Treatment difference | -0.5 (95% CI -1.1–0.2) |
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