drugset / Trial / NCT03221088
A Study of PEG-somatropin in the Treatment of Children With Idiopathic Short Stature
Phase 2
Unknown
360 enrolled
Changchun GeneScience Pharmaceutical Co., Ltd.
Affiliated Hospital of Jiangnan University · collabChildren's Hospital of Fudan University · collabShanghai Children's Hospital · collabThe Children's Hospital of Zhejiang University School of Medicine · collabThe First Affiliated Hospital with Nanjing Medical University · collabThe First Hospital of Jilin University · collabTongji Hospital · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
This study aims to explore the optimal dose of pegylated recombinant human growth hormone (PEG-rhGH) injection to treat children with idiopathic short stature (ISS), evaluate its safety and efficacy, and provide scientific and reliable evidence for the medication dosage in Phase III clinical study.
Timeline
- Start
- 2015-06
- Primary completion
- 2018-12
- Completion
- —
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | PEG-somatropin | Protein / enzyme biologic | 0.1 mg/kg | Subcutaneous |
| Subject | PEG-somatropin | Protein / enzyme biologic | 0.2 mg/kg | Subcutaneous |
Indications
No indication recorded.