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| Name | Class |
|---|---|
| Beijing Children's Hospital | OTHER |
| Tianjin Medical University General Hospital | OTHER |
| Peking University Third Hospital | OTHER |
| China-Japan Friendship Hospital |
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To Evaluate the safety and efficacy of PEG Somatropin in the treatment of children with growth hormone deficiency, as well as to study the dosage of PEG Somatropin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PEG-somatropin | Experimental | 30IU/10 mg/3ml/kit, 0.1-0.2mg /kg/w, once per day for 26 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PEG-somatropin | Biological | 30IU/10 mg/3ml/kit, 0.1-0.2mg /kg/w, once per day for 26 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ht SDSca (Height Standard Deviation Score for Chronological Age) | 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 |
| Change of yearly growth velocity from baseline to 26 weeks | Height velocity calculate by formula | Baseline, 26 weeks after initiating treatment |
| 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 | 26 weeks after initiating treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Ht SDSBA (Height Standard Deviation Score for Bone Age) | Baseline,26 weeks after initiating treatment | |
| IGF-1 SDS (IGF-1 Standard Deviation Score) | Baseline,26 weeks after initiating treatment | |
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Inclusion Criteria:
Diagnosed as GHD before starting treatment, according to medical history, clinical symptoms and signs, GH provocation tests and imaging and other examinations:
Before puberty (Tanner I stage), age≥3 years old, male or female;
Have not received hormone therapy within 6 months;
Subjects is willing and able to cooperate to complete scheduled visits, treatment plans and laboratory tests and other procedures, to sign informed consent.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaohua Feng | Contact | 13610794989 | fengxiaohua@gensci-china.com |
| Name | Affiliation | Role |
|---|---|---|
| Chunxiu Gong | Beijing Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anhui Provincial Children's Hospital | Recruiting | Hefei | Anhui | China | ||
| Fuzhou Children s Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35945517 | Derived | Chen J, Zhong Y, Wei H, Chen S, Su Z, Liu L, Liang L, Lu P, Chen L, Chen R, Ni S, Wang X, Li L, Wang Y, Xu X, Xiao Y, Yao H, Liu G, Jin R, Cao B, Wu D, Su C, Li W, Qin M, Li X, Luo X, Gong C. Polyethylene glycol recombinant human growth hormone in Chinese prepubertal slow-growing short children: doses reported in a multicenter real-world study. BMC Endocr Disord. 2022 Aug 9;22(1):201. doi: 10.1186/s12902-022-01101-8. |
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| OTHER |
| Dalian Children's Hospital | OTHER |
| Xian Children's Hospital | OTHER_GOV |
| Wuhan Children's Hospital | OTHER |
| Fuzhou Children s Hospital | UNKNOWN |
| Anhui Provincial Children's Hospital | OTHER |
| Hunan Children's Hospital | OTHER_GOV |
| Shenzhen Children's Hospital | OTHER_GOV |
| Children's Hospital of Hebei Province | OTHER |
| Second Affiliated Hospital of Xi'an Jiaotong University | OTHER |
| Zhengzhou Children's Hospital, China | OTHER |
| Children's Hospital of Soochow University | OTHER |
| Maternal and Child Health Hospital of Guangxi Zhuang Autonomous Region | OTHER |
| First Affiliated Hospital of Kunming Medical University | OTHER |
| Kunming Children's Hospital | OTHER |
| The First People's Hospital of Yunnan | OTHER |
| Xuzhou Children's Hopspital | UNKNOWN |
| Henan Provincial People's Hospital | OTHER |
| The First Affiliated Hospital of Henan University of Traditional Chinese Medicine | OTHER |
| First Affiliated Hospital of Harbin Medical University | OTHER |
| The Second Hospital of Hebei Medical University | OTHER |
| Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | OTHER |
| Union Hospital of Tongji Medical College of HUST | UNKNOWN |
| Wuxi Women's & Children's Hospital | OTHER |
| The Second Affiliated Hospital of Kunming Medical University | OTHER |
| Nanjing Children's Hospital | OTHER |
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| IGFBP-3 SDS (IGFBP-3 Standard Deviation Score) |
| Baseline,26 weeks after initiating treatment |
| Skeletal maturity | Skeletal maturity=(Bone Age at 26 weeks-Bone Age at baseline)/treatment duration | Baseline,26 weeks after initiating treatment |
| Recruiting |
| Fuzhou |
| Fujian |
| China |
| Sun Yat-Sen Memorial Hospital | Recruiting | Guangzhou | Guangdong | China |
| The Second Hospital of Hebei Medical University | Recruiting | Shijiangzhuang | Hebei | China |
| Children's Hospital of Hebei Province | Recruiting | Shijiazhuang | Hebei | China |
| The First Affiliated Hospital of Harbin Medical University | Recruiting | Harbin | Heilongjiang | China |
| Children's Hospital of Zhengzhou | Recruiting | Zhengzhou | Henan | China |
| Henan Provincal People's Hospital | Recruiting | Zhengzhou | Henan | China |
| The First Affiliated Hospital of Henan University of TCM | Recruiting | Zhengzhou | Henan | China |
| Union Hospital, Tongji Medical College, HUST | Recruiting | Wuhan | Hubei | China |
| Wuhan Children's Hospital | Recruiting | Wuhan | Hubei | China |
| Hunan Children's Hospital | Recruiting | Changsha | Hunan | China |
| Maternal & Child Health Hospital of Guangxi Zhuang Autonomous Region | Recruiting | Nanjing | Jiangsu | China |
| Nanjing Children's Hospital | Recruiting | Nanjing | Jiangsu | China |
| Children's Hospital of Soochow University | Recruiting | Suzhou | Jiangsu | China |
| Wuxi Children's Hospital | Recruiting | Wuxi | Jiangsu | China |
| Xuzhou Children's Hpspital | Recruiting | Xuzhou | Jiangsu | China |
| Dalian Children's Hospital | Recruiting | Dalian | Liaoning | China |
| The Second Affiliated Hospital of Xi'an Jiaotong University | Recruiting | Xi’an | Shanxi | China |
| Xi'an Children's Hospital | Recruiting | Xi’an | Shanxi | China |
| First Affiliated Hospital of Kunming Medical University | Recruiting | Kunming | Yunnan | China |
| Kunming Children's Hospital | Recruiting | Kunming | Yunnan | China |
| Second Affiliated Hospital of Kunming Medical University | Recruiting | Kunming | Yunnan | China |
| The First People's Hospital of Yunnan Province | Recruiting | Kunming | Yunnan | China |
| China-Japan Friendship Hospital | Recruiting | Beijing | China |
| Peking University Third Hospital | Recruiting | Beijing | China |
| Shenzhen Children's Hospital | Recruiting | Shenzhen | China |
| Tianjin Medical University General Hospital | Recruiting | Tianjin | 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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