drugset / Trial / NCT04326374
Safety, Tolerability and Efficacy of TransCon hGH Weekly Versus Daily hGH in Chinese Pediatric Growth Hormone Deficiency
Phase 3
Unknown
150 enrolled
Visen Pharmaceuticals (Shanghai) Co., Ltd.
Ascendis Pharma A/S · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
This study is conducted in China only. The purpose is to demonstrate the efficacy and safety of once weekly dosing of TransCon hGH, a long-acting growth hormone product, compare to once-daily dosing of human growth hormone (hGH) after 52 weeks of treatment in prepubertal children with growth hormone deficiency (GHD).
Timeline
- Start
- 2019-12-30
- Primary completion
- 2022-04
- Completion
- 2022-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Daily hGH | Protein / enzyme biologic | — | Subcutaneous |
| Subject | TransCon hGH | Protein / enzyme biologic | — | Subcutaneous |