drugset / Trial / NCT03104010
A Non-inferiority Phase 2 Study to Evaluate the Safety and Efficacy of PEG-rhGH in the Treatment of AGHD
Phase 2
Unknown
180 enrolled
Changchun GeneScience Pharmaceutical Co., Ltd.
Chongqing Three Gorges Central Hospital · collabFirst Affiliated Hospital of Chongqing Medical University · collabHebei General Hospital · collabPeking Union Medical College Hospital · collabPeking University First Hospital · collabQilu Hospital of Shandong University · collabSecond Affiliated Hospital, School of Medicine, Zhejiang University · collabThe First Affiliated Hospital of Soochow University · collabThe Second Hospital of Hebei Medical University · collabWest China Hospital · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
This study aims to explore the optimal dose of PEG-rhGH injection in the treatment of AGHD, preliminarily evaluate its safety and efficacy, to provide scientific and reliable evidence for the medication dosage in Phase 2 clinical study.
Timeline
- Start
- 2017-04
- Primary completion
- 2022-02
- Completion
- 2022-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Somatropin | Protein / enzyme biologic | 0.17 mg | Subcutaneous |
| Subject | Somatropin | Protein / enzyme biologic | 0.68 mg | Subcutaneous |