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This is a multicenter, randomized, open-label, active-controlled Phase III clinical trial to evaluate the efficacy and safety of Inpegsomatropin injection,once a week,compared with recombinant human growth hormone (rhGH) in children with short stature born small for gestational age (SGA).It plans to enroll 141 children with short stature born small for gestational age (SGA), who will be stratified by gender and age and randomized in a 1:1:1 ratio to either Experimental Group 1, Experimental Group 2, or the Active Control Group. All participants will undergo a screening period (up to 12 weeks), a treatment period (52 weeks), and a post-treatment follow-up period (5 weeks). Safety and efficacy will be comprehensively evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Group 1 | Experimental |
| |
| Experimental Group 2 | Experimental |
| |
| rhGH group | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inpegsomatropin Injection | Drug | Inpegsomatropin injection, 140 μg/kg/week, s.c., once weekly, for 52 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Growth velocity (HV, cm/year). | Week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in height standard deviation score from baseline (△HT SDS) | From baseline to all follow-up time points at Week 52 | |
| Change in growth velocity from baseline (△HV) | From baseline to all follow-up time points at Week 52 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaoping Luo, Ph.D | Contact | 15671671188 | xpluo@tjh.tjmu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Xiaoping Luo, Ph.D | Tongji Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Children's Hospital, Capital Medical University | Recruiting | Beijing | China |
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| Inpegsomatropin Injection | Drug | Inpegsomatropin injection, 280 μg/kg/week, s.c., once weekly, for 52 weeks. |
|
| Recombinant Human Growth Hormone Injection | Drug | Recombinant human growth hormone injection, 0.033mg/kg/day, s.c.,once daily, for 52 weeks. |
|
| Change in insulin-like growth factor 1 standard deviation score from baseline (△IGF-1 SDS) | From baseline to all follow-up time points at Week 52 |
| Ratio of the change in bone age to the change in chronological age | Week 52 |
| Beijing Children's Hospital, Capital Medical University | Recruiting | Beijing | China |
|
| Peking Union Medical College Hospital, Chinese Academy of Medical Sciences | Recruiting | Beijing | China |
|
| The First Hospital of Jilin University | Recruiting | Changchun | China |
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| Hunan Children's Hospital | Recruiting | Changsha | China |
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| Chengdu Women's and Children's Central Hospital | Recruiting | Chengdu | China |
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| West China Second University Hospital, Sichuan University | Recruiting | Chengdu | China |
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| Children's Hospital of Chongqing Medical University | Recruiting | Chongqing | China |
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| Fuzhou First General Hospital | Recruiting | Fuzhou | China |
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| Guangzhou Women and Children's Medical Center, Guangzhou Medical University | Recruiting | Guangzhou | China |
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| Sun Yat-sen Memorial Hospital, Sun Yat-sen University | Recruiting | Guangzhou | China |
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| The First Affiliated Hospital of Sun Yat-sen University | Recruiting | Guangzhou | China |
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| The Third Affiliated Hospital of Sun Yat-sen University | Recruiting | Guangzhou | China |
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| Hainan Women and Children's Medical Center | Recruiting | Haikou | China |
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| The First Affiliated Hospital, Zhejiang University School of Medicine | Recruiting | Hangzhou | China |
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| Heilongjiang Provincial Hospital | Recruiting | Harbin | China |
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| Anhui Children's Hospital | Recruiting | Hefei | China |
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| The Second Affiliated Hospital of Anhui Medical University | Recruiting | Hefei | China |
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| Inner Mongolia People's Hospital | Recruiting | Hohhot | China |
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| Shandong Provincial Hospital | Recruiting | Jinan | China |
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| Affiliated Hospital of Jining Medical University | Recruiting | Jining | China |
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| Jiujiang Maternal and Child Health Hospital | Recruiting | Jiujiang | China |
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| Kunming Children's Hospital | Recruiting | Kunming | China |
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| Gansu Provincial Maternity and Child-care Hospital (Gansu Provincial Central Hospital) | Recruiting | Lanzhou | China |
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| Liuzhou People's Hospital | Recruiting | Liuzhou | China |
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| The First Affiliated Hospital of Henan University of Science and Technology | Recruiting | Luoyang | China |
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| Jiangxi Provincial Children's Hospital | Recruiting | Nanchang | China |
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| The Second Affiliated Hospital of Nanchang University | Recruiting | Nanchang | China |
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| Nanjing Children's Hospital | Recruiting | Nanjing | China |
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| Ningbo Women and Children's Hospital, Ningbo University | Recruiting | Ningbo | China |
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| Qujing Maternal and Child Health Hospital | Recruiting | Qujing | China |
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| Sanya Central Hospital (Hainan Third People's Hospital) | Recruiting | Sanya | China |
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| Shanghai Children's Hospital | Recruiting | Shanghai | China |
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| Shanghai Children's Medical Center, Shanghai Jiao Tong University School of Medicine | Recruiting | Shanghai | China |
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| Xinhua Hospital, Shanghai Jiao Tong University School of Medicine | Recruiting | Shanghai | China |
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| Shengjing Hospital of China Medical University | Recruiting | Shenyang | China |
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| Children's Hospital of Soochow University | Recruiting | Suzhou | China |
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| Tianjin Medical University General Hospital | Recruiting | Tianjin | China |
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| The First Affiliated Hospital of Xinjiang Medical University | Recruiting | Ürümqi | China |
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| The Second Affiliated Hospital of Wenzhou Medical University | Recruiting | Wenzhou | China |
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| Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology | Recruiting | Wuhan | China |
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| Wuhan Children's Hospital | Recruiting | Wuhan | China |
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| Wuxi Children's Hospital | Recruiting | Wuxi | China |
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| The First Affiliated Hospital of Xiamen University | Recruiting | Xiamen | China |
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| Xiamen Maternal and Child Health Hospital | Recruiting | Xiamen | China |
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| Xuzhou Children's Hospital | Recruiting | Xuzhou | China |
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| Yuncheng Central Hospital, Shanxi Province | Recruiting | Yuncheng | China |
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| Henan Children's Hospital (Zhengzhou Children's Hospital) | Recruiting | Zhengzhou | China |
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| Zhuzhou Central Hospital | Recruiting | Zhuzhou | China |
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| ID | Term |
|---|---|
| D013006 | Growth Hormone |
| ID | Term |
|---|---|
| D010908 | Pituitary Hormones, Anterior |
| D010907 | Pituitary Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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