drugset / Trial / NCT02908958
Clinical Study of Pegylated Somatropin to Treat Children Growth Hormone Deficiency
Phase 4
Unknown
900 enrolled
Changchun GeneScience Pharmaceutical Co., Ltd.
Central South University · collabFirst Affiliated Hospital of Guangxi Medical University · collabFirst People's Hospital of Hangzhou · collabGuangzhou Women and Children's Medical Center · collabQilu Hospital of Shandong University · collabSecond Affiliated Hospital of Wenzhou Medical University · collabShanghai Children's Medical Center · collabShaoxing Second Hospital · collabSouthwest Hospital, China · collabThe Children's Hospital of Zhejiang University School of Medicine · collabThe First Affiliated Hospital of Xiamen University · collabThe Second Hospital of Anhui Medical University · collabThird Affiliated Hospital, Sun Yat-Sen University · collabXiangya Hospital of Central South University · collabZhejiang Provincial Hospital of TCM · collabZhejiang Provincial People's Hospital · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
To evaluate the safety and efficacy of PEG Somatropin Injection (Jintrolong®) in the treatment of short stature due to endogenous growth hormone deficiency (GHD) in the broad of population of children.
Timeline
- Start
- 2014-11
- Primary completion
- 2017-06
- Completion
- —
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | PEG-somatropin | Protein / enzyme biologic | 0.14 mg/kg | Subcutaneous |
| Subject | PEG-somatropin | Protein / enzyme biologic | 0.2 mg/kg | Subcutaneous |