drugset / Trial / NCT04970654
A Research Study in Chinese Children With a Low Level of Hormone to Grow. Treatment is Somapacitan Once a Week Compared to Norditropin® Once a Day.
RandomizedParallel-groupOpen-labelTreatment
Summary
The study compares two medicines for children with a low level of hormone to grow: somapacitan (a new medicine) given once a week and Norditropin® (a medicine doctors can already prescribe) given once a day. Researchers will test somapacitan to see how well it works, compared to the standard treatment with Norditropin®. The participants will either get Norditropin® once every day or somapacitan once every week - which treatment the participant gets is decided by chance. The participant and the study doctor will know which treatment the participant gets. The study includes a 52 week treatment period and a minimum of 30 days follow up period.
Timeline
- Start
- 2021-07-22
- Primary completion
- 2023-11-17
- Completion
- 2023-12-18
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Somatropin | Protein / enzyme biologic | 0.034 mg/kg | Subcutaneous |
| Subject | somapacitan | Protein / enzyme biologic | 0.16 mg/kg | Subcutaneous |