Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
NOT YET RECRUITING
NCT07614152
PHASE3

The Efficacy and Safety of Inpegsomatropin Injection in Children With Turner Syndrome (TS) and Short Stature

Sponsor: Xiamen Amoytop Biotech Co., Ltd.

View on ClinicalTrials.gov

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

DRUG

Inpegsomatropin-Injection

Inpegsomatropin injection, 280 μg/kg/week, s.c., once weekly, for 52 weeks.

DRUG

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