Efficacy and Safety Study of Sr-hGH in Comparison With Daily hGH in ISS Patients
Summary
The purpose of this study is to assess dosing requirements and establish the efficacy of SR-hGH in idiopathic short stature patients (ISS). This phase II study is designed as multi-center, randomized, active comparator-controlled, parallel, open-label. 45 patients were randomized to three arms with 1:1:1 ratio, two arms of Sr-hGH and one of daily hGH. Two doses of Sr-hGH were administered, which are 0.5 and 0.7mg/kg/week. And the other arm received daily hGH at 0.37 mg/kg/week. Patients in Sr-hGH groups injected on a specific day of the every week for 26 weeks. And patients randomized to daily hGH group injected for 6 days a week. Patients visited study centers five times, firstly at screening (Visit 1), at randomization (Visit 2), after 13th dosing (Visit 3), after 26th dosing (Visit 4), and finally for follow-up (Visit5).
Timeline
- Start
- 2014-02
- Primary completion
- 2015-03
- Completion
- 2015-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Somatropin | Protein / enzyme biologic | 0.37 mg/kg | — |
| Subject | Somatropin | Protein / enzyme biologic | 0.5 mg/kg | — |
| Subject | Somatropin | Protein / enzyme biologic | 0.7 mg/kg | — |
Indications
No indication recorded.