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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
180
Recombinant human growth hormone injection, 15IU/5mg/3ml/bottle. The first stage , 0.17mg/d(0.5IU/d), subcutaneous injection ,daily, 26weeks. The second stage(extension period study), 0.17mg/d(0.5IU/d), maximum ≤0.68mg/d (2IU/w),52 weeks.
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
NOT_YET_RECRUITINGHeibei General Hospital
Shijiazhuang, Hebei, China
NOT_YET_RECRUITINGThe Affiliated hospital of soochow University
Fat mass change
Change from baseline in fat mass (torso) (FM): FM at the end of treatment minus the baseline value
Time frame: 52 weeks
Lean body mass change
Change from baseline in lean body mass (LBM): LBM at the end of treatment minus the baseline value
Time frame: 52 weeks
Blood lipid change
Change from baseline in blood lipid: blood lipid at the end of treatment minus the baseline value
Time frame: 52 weeks
Waist circumference change
Change from baseline in waist circumference: waist circumference at the end of treatment minus the baseline value
Time frame: 52 weeks
Percentage of body fat change
Change from baseline in the percentage of body fat: TBF at the end of treatment minus the baseline value
Time frame: 52 weeks
Cardiac function change
Change from baseline in cardiac function: ejection fraction at the end of treatment minus the baseline value
Time frame: 52 weeks
Cardiac structure change
Change from baseline in cardiac structure: left ventricular mass at the end of treatment minus the baselines value
Time frame: 52 weeks
IGF-1 change
Changes from baseline in IGF-1: IGF-1 SDS at the end of treatment minus the baseline value
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Suzhou, Jiangsu, China
Qilu Hospital of Shandong University
Jinan, Shandong, China
NOT_YET_RECRUITINGWest China Hospital, Sichuan University
Chengdu, Sichuan, China
NOT_YET_RECRUITINGThe Second Affiliated Hospital of Zhejiang University school of medicine
Hangzhou, Zhejiang, China
NOT_YET_RECRUITINGPeking Union Medical College Hospital
Beijing, China
RECRUITINGChongqing Three Gorges Central Hospital
Chongqing, China
NOT_YET_RECRUITINGThe First Affiliated Hospital of Chongqing Medical University
Chongqing, China
NOT_YET_RECRUITINGTime frame: 52 weeks
Grip change
Changes from baseline in grip: grip at the end of treatment minus the baseline value, the method of assessment is measurement.
Time frame: 52 weeks
Quality of life change
Changes from baseline in quality of life (QOL): changes in QOL scores before and after treatment
Time frame: 52 weeks
Waist-hip ratio change
Changes from baseline in waist-hip ratio: changes of waist-hip ratio before and after treatment
Time frame: 52 weeks
Cardiac structure change
Change from baseline in cardiac structure: carotid intima media thickness at the end of treatment minus the baselines value
Time frame: 52 weeks