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| Name | Class |
|---|---|
| Children's Hospital of Fudan University | OTHER |
| Suzhou Municipal Hospital | OTHER |
| General Hospital of Ningxia Medical University | OTHER |
| The First Affiliated Hospital of Henan University of Science and Technology |
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To evaluate the safety and efficacy of PEG Somatropin Injection in the treatment of children with growth hormone deficiency, as well as to study the feasibility of extending the dosing intervals (once per two weeks) of PEG Somatropin Injection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PEG-somatropin | Experimental | Pegylated somatropin, injection, 54IU/9.0mg/1.0ml/kit Group of dosing per week:0.20 mg /kg/w, once per week for 26 weeks |
|
| PEG-somatropin per two weeks | Experimental | Pegylated somatropin, injection, 54IU/9.0mg/1.0ml/kit Group of dosing per two weeks:0.20 mg /kg/2w,once per two weeks for 26 weeks |
|
| Jintropin AQ | Active Comparator | Jintropin AQ, injection, 30IU/10 mg/3ml/cartridge, 0.25mg/kg/w, once per day for 26 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PEG-somatropin | Biological | Pegylated somatropin, injection, 54IU/9.0mg/1.0ml/bottle Group of dosing per week:0.20 mg /kg/w, once per week for 26 weeks |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Ht SDSBA | Calculate by formula | Baseline, 4,12,26 weeks after initiating treatment |
| Yearly growth velocity | Calculate by formula | Baseline, 4,12,26 weeks after initiating treatment |
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Inclusion Criteria:
Subjects are 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;
Subjects 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 |
|---|---|---|
| Feihong Luo, Doctor | Children's Hospital of Fudan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maternal and Child Health Hospital of Anhui province | Recruiting | Hefei | Anhui | China | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34899612 | Derived | Sun C, Lu B, Liu Y, Zhang Y, Wei H, Hu X, Hu P, Zhao Q, Liu Y, Ye K, Wang K, Gu Z, Liu Z, Ye J, Zhang H, Zhu H, Jiang Z, Liu Y, Wan N, Yan C, Yin J, Ying L, Huang F, Yin Q, Xi L, Luo F, Cheng R. Reduced Effectiveness and Comparable Safety in Biweekly vs. Weekly PEGylated Recombinant Human Growth Hormone for Children With Growth Hormone Deficiency: A Phase IV Non-Inferiority Threshold Targeted Trial. Front Endocrinol (Lausanne). 2021 Nov 25;12:779365. doi: 10.3389/fendo.2021.779365. eCollection 2021. |
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| OTHER |
| Maternal and Child Health Hospital of Hubei Province | OTHER |
| Nantong University | OTHER |
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| PEG-somatropin | Biological | Pegylated somatropin, injection, 54IU/9.0mg/1.0ml/bottle Group of dosing per two weeks:0.20 mg /kg/2w,once per two weeks for 26 weeks |
|
| IGF-1SDS | Calculate by formula | Baseline, 4,12,26 weeks after initiating treatment |
| IGF-1/IGFBP-3 molar ratio | Calculate by formula | Baseline, 4,12,26 weeks after initiating treatment |
| Bone age | Calculate by formula | Baseline, 4,12,26 weeks after initiating treatment |
| First People's Hospital of Lu'an City |
| Recruiting |
| Lu'an |
| Anhui |
| China |
| Second Hospital of Lanzhou University | Recruiting | Lanzhou | Gansu | China |
| Maternal and Child Health Hospital of Guiyang City | Recruiting | Guiyangtou | Guizhou | China |
| Maternal and Child Health Hospital of Hainan province | Recruiting | Haikou | Hainan | China |
| Hebei Provincial People's Hospital | Recruiting | Shijiazhuang | Hebei | China |
| First Affiliated Hospital of Henan University of Science and Technology | Recruiting | Zhengzhou | Henan | China |
| Maternal and Child Health Hospital of Hubei province | Recruiting | Wuhan | Hubei | China |
| First People's Hospital of Changzhou City | Recruiting | Changzhou | Jiangsu | China |
| First People's Hospital of Lianyungang City | Recruiting | Lianyungang | Jiangsu | China |
| Jiangsu Provincial Hospital of Chinese Traditional medicine | Recruiting | Nanjingkou | Jiangsu | China |
| Affiliated Hospital of Nantong University | Recruiting | Nantong | Jiangsu | China |
| Suzhou City Hospital | Recruiting | Suzhou | Jiangsu | China |
| Second Affiliated Hospital of Nanchang University | Recruiting | Nanchang | Jiangxi | China |
| Maternal and Child Health Hospital of Tai'an city | Recruiting | Tai’an | Shandong | China |
| Children's Hospital of Chengdu city | Recruiting | Chengdu | Sichuan | China |
| People's Hospital of Cixi City | Recruiting | Cixi | Zhejiang | China |
| First People's Hospital | Recruiting | Hangzhou | Zhejiang | China |
| First People's Hospital of Jiaxing City | Recruiting | Jiaxing | Zhejiang | China |
| Jinhua Central Hospital | Recruiting | Jinhua | Zhejiang | China |
| Jishuitan Hospital of Beijing City | Recruiting | Beijing | China |
| Peoples' hospital of Inner Mongolia Autonomous Region | Recruiting | Inner Mongolia Autonomous Region | China |
| General Hospital of Ningxia Medical University | Recruiting | Ningxia Autonomous Region | China |
| Children's Hospital of Fudan University | 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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