A Research Study in Children Born Small and Who Stayed Small. Treatment is Somapacitan Once a Week Compared to Norditropin® Once a Day
第2相
実施中（募集終了）
NCT03878446
| 対象疾患 | Short Stature Children Born Small for Gestational Age |
|---|
| 相 | 第2相 |
|---|
| スポンサー | Novo Nordisk A/S |
|---|
| ステータス | 実施中（募集終了） |
|---|
| 参加者数 | 62 名 |
|---|
| 介入（薬剤） | Somapacitan, Norditropin® |
|---|
| 開始日 | 2019年7月4日 |
|---|
| 完了日 | 2021年5月5日 |
|---|
| 結果公開日 | 2024年6月20日 |
|---|
概要
The study compares 2 medicines used for the treatment of children who are born small and who stayed small: somapacitan given once a week (a new medicine) and Norditropin® given once a day (the medicine doctors can already prescribe). Participants will either get somapacitan or Norditropin® - which treatment is decided by chance. Both participants and the study doctor will know which treatment the participants get. The study will last for 5 years. Participants will take either an injection once every week or once every day.
Height Velocity
Baseline (week 0); week 26 · centimeter per year (cm/year)
| Norditropin 0.035 mg/kg/Day | 10.5 ± 2.0 centimeter per year (cm/year) |
|---|
| Norditropin 0.067 mg/kg/Day | 11.9 ± 2.4 centimeter per year (cm/year) |
|---|
| Somapacitan 0.16 mg/kg/Week | 8.9 ± 1.8 centimeter per year (cm/year) |
|---|
| Somapacitan 0.20 mg/kg/Week | 11.1 ± 2.6 centimeter per year (cm/year) |
|---|
| Somapacitan 0.24 mg/kg/Week | 11.2 ± 3.4 centimeter per year (cm/year) |
|---|
| Treatment difference | -1.4 (95% CI -3.2–0.4) |
|---|
BENITIONS で見る
ClinicalTrials.gov の原文を見る
すべての治験
このページは ClinicalTrials.gov の公開データをまとめたものです。医学的助言ではなく、投資助言でもありません。必ず専門医にご相談ください。