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This study evaluates the safety and efficiency of Pegylated Somatropin (PEG Somatropin) Injection in the treatment of endogenous growth hormone deficiency (GHD) in the broad of population of children.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PEG-somatropin | Experimental | 0.12mg/kg/w |
|
| PEG-Somatropin | Experimental | 0.20mg/kg/w |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PEG-somatropin | Biological | 0.20mg/kg/w |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Ht SDSca | Ht SDSca was calculated by dividing the difference between the actual height of a patient and the mean height of the population for that chronological age by the standard deviation (SD) of the height of the population for that chronological age | Baseline, 4,12,26 weeks after initiating treatment |
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Inclusion Criteria:
Before starting treatment, according to the medical history, clinical symptoms and signs, GH stimulation test and imaging examination, patients are diagnosed as GHD.
Be in preadolescence (Tanner stage 1) and have a CA ≧ 3 years.
Receive no prior GH treatment within 6 months.
Sign informed consent.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaohua Feng | Contact | 13610794989 | fengxiaohua@gensci-china.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital Affiliated to Capital Institute of Pediatrics | Recruiting | Beijing | Beijing Municipality | China |
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| PEG-somatropin |
| Biological |
0.12mg/kg/w |
|
| Chinese Academy of Medical Sciences &Peking Union Medical College | Recruiting | Beijing | Beijing Municipality | China |
| The First Affiliated Hospital of Nanjing Medical University | Recruiting | Nanjing | Jiangsu | China |
| Affiliated Hospital, Jiangnan University | Recruiting | Wuxi | Jiangsu | China |
| First Hospital of Jilin University | Recruiting | Changchun | Jilin | China |
| Shandong Provincial Hospital | Recruiting | Jinan | Shandong | China |
| The Affiliated Hospital of Qingdao University | Recruiting | Qingdao | Shandong | China |
| Children's Hospital of Fudan University | Recruiting | Shanghai | Shanghai Municipality | China |
| Children's Hospital of Shanghai | Recruiting | Shanghai | Shanghai Municipality | China |
| West China Second University Hospital | Recruiting | Chengdu | Sichuan | China |
| The First Affiliated Hospital, Zhejiang University | Recruiting | Hangzhou | Zhejiang | China |
| Xin Hua Hospital Affiated to Shanghai Jiao Tong University School of Medicine | Recruiting | Shanghai | China |
| ID | Term |
|---|---|
| D004393 | Dwarfism, Pituitary |
| ID | Term |
|---|---|
| D004392 | Dwarfism |
| D001848 | Bone Diseases, Developmental |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D001849 | Bone Diseases, Endocrine |
| D007018 | Hypopituitarism |
| D010900 | Pituitary Diseases |
| D007027 | Hypothalamic Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D004700 | Endocrine System Diseases |
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