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)
Фаза 3
Завершено
NCT03811535
| Заболевание | Growth Hormone Deficiency in Children |
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| Фаза | Фаза 3 |
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| Спонсор | Novo Nordisk A/S |
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| Статус | Завершено |
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| Участники | 200 участн. |
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| Вмешательство | Somapacitan, Norditropin® |
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| Дата начала | 20.05.2019 |
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| Дата завершения | 10.11.2021 |
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| Публикация результатов | 4.08.2023 |
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Кратко
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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