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| Name | Class |
|---|---|
| Tongji Hospital | OTHER |
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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 idiopathic short stature (ISS). It plans to enroll 300 children with ISS, who will be randomized , stratified by gender and age, and assigned to either the experimental group or the positive controlled group. Each participant will undergo a screening period (up to 12 weeks), a treatment period (52 weeks), and a post-treatment follow-up period (5 weeks). And the safety and efficacy will be evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Inpegsomatropin group | Experimental |
| |
| rhGH group | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inpegsomatropin Injection | Drug | Inpegsomatropin injection, 280 μg/kg/week, s.c., once weekly, for 52 consecutive weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Growth velocity (HV, cm/year). | Week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in height standard deviation score from baseline (â–³HT SDS) | From baseline to all follow-up time points at Week 52 | |
| Change in growth velocity from baseline (â–³HV) | 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 |
|---|---|---|---|---|---|---|
| Anhui Provincial Children's Hospital | Recruiting | Hefei | Anhui | China |
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| Recombinant Human Growth Hormone Injection | Drug | Recombinant Human Growth Hormone Injection, 350 μg/kg/week, s.c., divided into 7 doses, i.e., 50 μg/kg/day (0.15 IU/kg/day), once daily for 52 consecutive weeks. |
|
| Change in insulin-like growth factor 1 standard deviation score from baseline (â–³IGF-1 SDS) | From baseline to all follow-up time points at Week 52 |
| The ratio of the change in bone age to the change in chronological age (â–³BA/â–³CA) | From baseline to all follow-up time points at Week 52 |
| The Second Affiliated Hospital of Anhui Medical University | Recruiting | Hefei | Anhui | China |
|
| Capital Institute of Pediatrics, Beijing (SHOUER) | Recruiting | Beijing | Beijing Municipality | China |
|
| Children's Hospital of Chongqing Medical University | Recruiting | Chongqing | Chongqing Municipality | China |
|
| The First Affiliated Hospital of Xiamen University | Recruiting | Xiamen | Fujian | China |
|
| Gansu Provincial Maternity and Child Care Hospital | Recruiting | Lanzhou | Gansu | China |
|
| Guangzhou Women and Children's Medical Center | Recruiting | Guangzhou | Guangdong | China |
|
| Sun Yat-sen Memorial Hospital, Sun Yat-sen University | Recruiting | Guangzhou | Guangdong | China |
|
| The Third Affiliated Hospital, Sun Yat-sen University | Recruiting | Guangzhou | Guangdong | China |
|
| Henan Children's Hospital Zhengzhou Children's Hospital | Recruiting | Zhengzhou | Henan | China |
|
| Wuhan Children's Hospital | Recruiting | Wuhan | Hubei | China |
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| Hunan Children's Hospital | Recruiting | Changsha | Hunan | China |
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| Children's Hospital Affiliated to Soochow University | Recruiting | Suzhou | Jiangsu | China |
|
| Jiangxi Provincial Children's Hospital | Recruiting | Nanchang | Jiangxi | China |
|
| Children's Hospital of Shanghai | Recruiting | Shanghai | Shanghai Municipality | China |
|
| Chengdu Women's and Children's Central Hospital | Recruiting | Chengdu | Sichuan | China |
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| West China Second University Hospital, Sichuan University | Recruiting | Chengdu | Sichuan | China |
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| The Affiliated Women's and Children's Hospital of Ningbo University | Recruiting | Ningbo | Zhejiang | China |
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| The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University | Recruiting | Wenzhou | Zhejiang | China |
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| Sanya Central Hospital | Recruiting | Hainan | China |
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| Hangzhou First People's Hospital | Recruiting | Hangzhou | China |
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| Zhejiang Provincial People's Hospital | Recruiting | Hangzhou | China |
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| The First Affiliated Hospital of Henan University of Science and Technology | Recruiting | Henan | China |
|
| Jiaxing First Hospital | Recruiting | Jiaxing | China |
|
| Affiliated Hospital of Jining Medical University | Recruiting | Jining | China |
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| Kunming Children's Hospital | Recruiting | Kunming | China |
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| Nanjing Children's Hospital | Recruiting | Nanjing | China |
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| Qingdao Women and Children's Hospital | Recruiting | Qingdao | China |
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| Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine | Recruiting | Shanghai | China |
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| Shanghai Children's Medical Center | Recruiting | Shanghai | China |
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| Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine | Recruiting | Shanghai | China |
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| The First Hospital of Hebei Medical University | Recruiting | Shijiazhuang | China |
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| Renmin Hospital of Wuhan University | Recruiting | Wuhan | China |
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| The Second Affiliated Hospital of Xi'an Jiaotong University | Recruiting | Xi'an | China |
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| Xiangyang Central Hospital | Recruiting | Xiangyang | China |
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| The First Affiliated Hospital of Xinjiang Medical University | Recruiting | Xinjiang | China |
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| Yuncheng Central Hospital | Recruiting | Yuncheng | China |
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| Zhuzhou Central Hospital | Recruiting | Zhuzhou | China |
|
| 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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