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)
3期
已完成
NCT03811535
| 适应症 | Growth Hormone Deficiency in Children |
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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 | 已完成 |
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| 受试者人数 | 200 人 |
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| 干预（药物） | Somapacitan, Norditropin® |
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| 开始日期 | 2019年5月20日 |
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| 完成日期 | 2021年11月10日 |
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| 结果公布日 | 2023年8月4日 |
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摘要
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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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。