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Phase 3 Study to Evaluate the Efficacy and Safety of Human Growth Hormone Injection (Sinotropin AQ) for the Treatment of Children With Idiopathic Short Stature
Sponsor: Zhongshan Sansure Hygene Biomedicine Co., Ltd.
Summary
This study is a multicenter, randomized, open-label, active-controlled, non-inferiority Phase III clinical trial. It aims to evaluate the efficacy and safety of Human Growth Hormone (hGH) Injection (Sinotropin AQ) in pediatric participants with Idiopathic Short Stature (ISS). Eligible participants will be randomized to receive either the study drug or an active comparator for 52 weeks. The primary efficacy endpoint is height velocity (HV, cm/year) over the treatment period. The study drug will be administered subcutaneously once daily at a dose of 0.15 IU/kg. The results of this trial will provide evidence on whether hGH Injection represents an effective and safe treatment option for improving height in children with ISS.
Official title: A Multicenter, Randomized, Open-Label, Active-Controlled, Non-Inferiority Phase 3 Study to Evaluate the Efficacy and Safety of Human Growth Hormone Injection (Sinotropin AQ) for the Treatment of Children With Idiopathic Short Stature (ISS)
Key Details
Gender
All
Age Range
3 Years - 11 Years
Study Type
INTERVENTIONAL
Enrollment
240
Start Date
2026-09
Completion Date
2029-02
Last Updated
2026-09-11
Healthy Volunteers
No
Conditions
Interventions
Human Growth Hormone (hGH)
This product is human growth hormone (hGH) injection (Sinotropin AQ). Usage and dosage: 0.15 IU/kg/day (0.05 mg/kg/day), once daily, administered by subcutaneous injection.
Human Growth Hormone (hGH)
This product is human growth hormone (hGH) injection. Usage and dosage: 0.15 IU/kg/day (0.05 mg/kg/day), once daily, administered by subcutaneous injection
Locations (34)
Anhui Provincial Children's Hospital
Hefei, Anhui, China
The Second Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
Capital Center for Children's Health, Captical Medical University
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China
Guangdong Hospital for Materal and Child Health Care
Guangzhou, Guangdong, China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
Tangshan Maternal and Child Health Hospital
Tangshan, Hebei, China
Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology
Wuhan, Hubei, China
Wuhan Children's Hospital
Wuhan, Hubei, China
Changsha Hospital for Maternal and Child Health Care
Changsha, Hunan, China
Hunan Children's Hospital
Changsha, Hunan, China
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China
The Third Xiangya Hospital of Central South University
Changsha, Hunan, China
Children's Hospital of Nanjing Medical University
Nanjing, Jiangsu, China
The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China
Wuxi Children's Hospital
Wuxi, Jiangsu, China
Jiangxi Provincial Children's Hospital
Nanchang, Jiangxi, China
Shengjing Hospital of China Medical University
Shenyang, Liaoning, China
Shandong Provincial Hospital
Jinan, Shandong, China
Qingdao Women and Children's Hospital
Qingdao, Shandong, China
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
Shanghai Children's Hospital
Shanghai, Shanghai Municipality, China
Shanghai Children's Medical Center Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
Shanxi Children's Hospital
Taiyuan, Shanxi, China
Chengdu Women's and Children's Central Hospital
Chengdu, Sichuan, China
West China Second University Hospital, Sichuan University
Chengdu, Sichuan, China
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, China
Kunming Children's Hospital
Kunming, Yunnan, China
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, China
Women and Children's Hospital of Ningbo University
Ningbo, Zhejiang, China
The Second Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China