The Efficacy and Safety of Inpegsomatropin Injection in Children With Idiopathic Short Stature
NCT ID: NCT06927310
Last Updated: 2025-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
300 participants
INTERVENTIONAL
2025-04-28
2028-06-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Inpegsomatropin group
Inpegsomatropin Injection
Inpegsomatropin injection, 280 μg/kg/week, s.c., once weekly, for 52 consecutive weeks.
rhGH group
Recombinant Human Growth Hormone Injection
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.
Interventions
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Recombinant Human Growth Hormone Injection
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.
Inpegsomatropin Injection
Inpegsomatropin injection, 280 μg/kg/week, s.c., once weekly, for 52 consecutive weeks.
Eligibility Criteria
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Inclusion Criteria
* Compared to chronological age, bone age is advanced by no more than 1 year or delayed by no more than 2 years (i.e., -2 years ≤ bone age - chronological age ≤ 1 year).
* Height at screening is below -2 standard deviations (SD) from the mean for age and sex, with height reference to Appendix 1.
* Body mass index (BMI) is within the 5th to 95th percentile for age and sex of healthy children, with reference to Appendix 2.
* Peak GH level ≥10.0 ng/ml in at least one GH stimulation test.
* No prior systemic pharmacological treatment for growth promotion (continuous use ≥1 month), including but not limited to growth hormone, insulin-like growth factor 1 (IGF-1), etc.
* The legal guardian understands and signs the informed consent form. If the participants is ≥8 years old, they must also sign the informed consent form. For participants under 8 years old who are able to express their consent, their assent should be clearly documented.
Exclusion Criteria
* Other types of growth and developmental abnormalities, including confirmed or highly suspected growth hormone deficiency (GHD), Noonan syndrome, Prader-Willi syndrome, Russell-Silver syndrome, Turner syndrome, small for gestational age, short stature due to SHOX gene abnormalities, growth delay due to malnutrition, growth delay due to hypothyroidism, and other short statures with a clear etiology; genetic testing results must be obtained before randomization to exclude short stature caused by definite genetic abnormalities;
* Individuals who have participated in any other clinical trial within 3 months prior to screening and have received pharmacological or non-pharmacological interventions;
* Individuals who received inhaled corticosteroids for more than 2 consecutive weeks, or oral or intravenous corticosteroids for more than 1 consecutive week, within the 3 months prior to screening;
* Individuals who are currently receiving or require long-term treatment with other therapies that may affect growth, including but not limited to methylphenidate, sex hormones, gonadotropin-releasing hormone analogs, aromatase inhibitors, anabolic agents, insulin, etc.;
* Individuals with abnormal liver or kidney function at screening (ALT \> 1.5 times the upper limit of normal, Cr \> upper limit of normal);
* Individuals diagnosed with diabetes mellitus, or with fasting blood glucose ≥6.1 mmol/L on two consecutive occasions;
* Individuals with chronic infectious diseases, such as chronic hepatitis B;
* Individuals with systemic chronic diseases, such as moderate to severe anemia, malnutrition, hypothyroidism, chronic kidney disease, cardiovascular diseases (e.g., dilated cardiomyopathy, etc.), psychiatric and psychological disorders, or those with congenital anomalies requiring clinical intervention as determined by the investigator;
* Individuals with congenital skeletal abnormalities, or those with scoliosis exceeding 15°, limping, or a history of slipped capital femoral epiphysis;
* Individuals with a history of increased intracranial pressure;
* Individuals with a history of malignancy or currently having active malignancy, including intracranial tumors;
* Individuals with severe allergic constitutions, or known allergies to growth hormone or its excipients;
* Individuals with any other disease that the investigator deems may endanger the subject's safety or compromise compliance with the study protocol.
3 Years
11 Years
ALL
No
Sponsors
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Tongji Hospital
OTHER
Xiamen Amoytop Biotech Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Xiaoping Luo, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Tongji Hospital
Locations
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Anhui Provincial Children's Hospital
Hefei, Anhui, China
The Second Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
Capital Institute of Pediatrics, Beijing (SHOUER)
Beijing, Beijing Municipality, China
Children's Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China
Gansu Provincial Maternity and Child Care Hospital
Lanzhou, Gansu, China
Guangzhou Women and Children's Medical Center
Guangzhou, Guangdong, China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
The Third Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
Henan Children's Hospital Zhengzhou Children's Hospital
Zhengzhou, Henan, China
Wuhan Children's Hospital
Wuhan, Hubei, China
Hunan Children's Hospital
Changsha, Hunan, China
Children's Hospital Affiliated to Soochow University
Suzhou, Jiangsu, China
Jiangxi Provincial Children's Hospital
Nanchang, Jiangxi, China
Children's Hospital of Shanghai
Shanghai, Shanghai Municipality, China
Chengdu Women's and Children's Central Hospital
Chengdu, Sichuan, China
West China Second University Hospital, Sichuan University
Chengdu, Sichuan, China
The Affiliated Women's and Children's Hospital of Ningbo University
Ningbo, Zhejiang, China
The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
Sanya Central Hospital
Hainan, , China
Hangzhou First People's Hospital
Hangzhou, , China
Zhejiang Provincial People's Hospital
Hangzhou, , China
The First Affiliated Hospital of Henan University of Science and Technology
Henan, , China
Jiaxing First Hospital
Jiaxing, , China
Affiliated Hospital of Jining Medical University
Jining, , China
Kunming Children's Hospital
Kunming, , China
Nanjing Children's Hospital
Nanjing, , China
Qingdao Women and Children's Hospital
Qingdao, , China
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, , China
Shanghai Children's Medical Center
Shanghai, , China
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, , China
The First Hospital of Hebei Medical University
Shijiazhuang, , China
Renmin Hospital of Wuhan University
Wuhan, , China
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an, , China
Xiangyang Central Hospital
Xiangyang, , China
The First Affiliated Hospital of Xinjiang Medical University
Xinjiang, , China
Yuncheng Central Hospital
Yuncheng, , China
Zhuzhou Central Hospital
Zhuzhou, , China
Countries
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Central Contacts
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Facility Contacts
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Yuqing Chen
Role: primary
Deyun Liu
Role: primary
Fuying Song
Role: primary
Min Zhu
Role: primary
Qun Lian
Role: primary
Bo Sun
Role: primary
Wen Zhang
Role: primary
Liyang Liang
Role: primary
Shunye Zhu
Role: primary
Haiyan Wei
Role: primary
Hui Yao
Role: primary
Yan Zhong
Role: primary
Haiying Wu
Role: primary
Yu Yang
Role: primary
Pin Li
Role: primary
Xinran Cheng
Role: primary
Fan Yang
Role: primary
Shuxia Ding
Role: primary
Xiaoou Shan
Role: primary
Hua Zhang
Role: primary
Chunming Jiang
Role: primary
Xiaoming Luo
Role: primary
Dan Lou
Role: primary
Shunfeng Mao
Role: primary
Meiyun Xin
Role: primary
Na Tao
Role: primary
Wei Gu
Role: primary
Tang Li
Role: primary
Wenli Lu
Role: primary
Xiumin Wang
Role: primary
Yu Ding
Role: backup
Huiwen Zhang
Role: primary
Huijuan Ma
Role: primary
Jingping Ye
Role: primary
Yanfeng Xiao
Role: primary
Rui Pan
Role: primary
Miregul Mamat
Role: primary
Sufang Chang
Role: primary
Xianglan Wen
Role: primary
Other Identifiers
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PEGPESEN-4-2-001
Identifier Type: -
Identifier Source: org_study_id