drugset / Trial / NCT03189160
A Study of PEG-somatropin Injection to Treat Children of Turner Syndrome
Phase 2
Unknown
180 enrolled
Changchun GeneScience Pharmaceutical Co., Ltd.
Affiliated Hospital of Jiangnan University · collabBeijing Children's Hospital · collabChildren's Hospital of Fudan University · collabJiangxi Province Children's Hospital · 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 · collabXinhua Hospital, Shanghai Jiao Tong University School of Medicine · 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 of Turner syndrome (TS), preliminarily evaluate its safety and efficacy and provide scientific and reliable evidence for the medication dosage in Phase 3 clinical trial.
Timeline
- Start
- 2016-03
- Primary completion
- 2018-03
- Completion
- —
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | PEG-rhGH | Protein / enzyme biologic | 0.1 mg/kg | Subcutaneous |
| Subject | PEG-rhGH | Protein / enzyme biologic | 0.2 mg/kg | Subcutaneous |