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The Efficacy and Safety of Inpegsomatropin Injection in Children With Turner Syndrome (TS) and Short Stature
Sponsor: Xiamen Amoytop Biotech Co., Ltd.
Summary
This is a multicenter, randomized, open-label, positive-controlled phase III confirmatory clinical study. A total of 84 children with short stature due to Turner Syndrome (TS) are planned to be enrolled. Stratified by age and karyotype, subjects will be randomized at a 1:1 ratio to either the test group or the positive control group with continuous treatment for 52 weeks. The study aims to compare the efficacy and safety of Inpegsomatropin-Injection versus Givopegsomatropin Solution Injection in children with TS-related short stature, so as to provide evidence for the new indication application of the investigational drug.
Official title: Multicenter, Randomized, Open-Label, Positive-Controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of Inpegsomatropin Injection Versus Givopegsomatropin Solution Injection in the Treatment of Short Stature in Children With Turner Syndrome.
Key Details
Gender
FEMALE
Age Range
2 Years - 12 Years
Study Type
INTERVENTIONAL
Enrollment
84
Start Date
2026-06-15
Completion Date
2030-02-28
Last Updated
2026-06-02
Healthy Volunteers
No
Conditions
Interventions
Inpegsomatropin-Injection
Inpegsomatropin injection, 280 μg/kg/week, s.c., once weekly, for 52 weeks.
Givopegsomatropin Solution Injection
Givopegsomatropin Solution Injection, 200 μg/kg/week, s.c., once weekly, for 52 weeks.
Locations (51)
Anyang Maternal and Child Health Hospital
Anyang, China
Beijing Children's Hospital, Capital Medical University
Beijing, China
Capital Institute of Pediatrics, Capital Medical University
Beijing, China
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Beijing, China
Peking University First Hospital
Beijing, China
The Second Xiangya Hospital of Central South University
Changsha, China
Chengdu Women's and Children's Central Hospital
Chengdu, China
Children's Hospital of Chongqing Medical University
Chongqing, China
The First Affiliated Hospital of Dalian Medical University
Dalian, China
Guangdong Provincial Maternal and Child Health Hospital
Guangzhou, China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, China
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, China
The Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, China
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, China
Zhejiang Provincial Hospital of Traditional Chinese Medicine
Hangzhou, China
The First Affiliated Hospital of Hebei North University
Hebei, China
The First Affiliated Hospital of Henan University of Science and Technology
Henan, China
Huzhou Central Hospital
Huzhou, China
Jiangxi Provincial Children's Hospital
Jiangxi, China
The First Hospital of Jilin University
Jilin, China
Shandong Provincial Hospital
Jinan, China
Affiliated Hospital of Jining Medical University
Jining, China
Kunming Children's Hospital
Kunming, China
Gansu Provincial People's Hospital
Lanzhou, China
The Second Affiliated Hospital of Guangxi Medical University
Nanning, China
Pingxiang People's Hospital
Pingxiang, China
Qilu Hospital of Shandong University
Qilu, China
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, China
Shanghai Children's Hospital
Shanghai, China
Shanghai Children's Medical Center, Shanghai Jiao Tong University School of Medicine
Shanghai, China
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, China
The Second Affiliated Hospital of Shaanxi University of Chinese Medicine
Shanxi, China
Shaoxing People's Hospital
Shaoxing, China
Shengjing Hospital of China Medical University
Shenyang, China
Shenzhen Children's Hospital
Shenzhen, China
West China Second University Hospital, Sichuan University
Sichuan, China
Children's Hospital of Soochow University
Suzhou, China
Taizhou First People's Hospital
Taizhou, China
Taizhou People's Hospital
Taizhou, China
Tangshan Maternal and Child Health Hospital
Tangshan, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, China
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, China
Wuhan Children's Hospital
Wuhan, China
Affiliated Hospital of Jiangnan University
Wuxi, China
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an, China
Xiamen Maternal and Child Health Hospital
Xiamen, China
Xiangyang First People's Hospital
Xiangyang, China
The First Affiliated Hospital of Xinjiang Medical University
Xinjiang, China
Yibin Second People's Hospital
Yibin, China
Henan Children's Hospital Zhengzhou Children's Hospital
Zhengzhou, China
Zibo Central Hospital
Zibo, China