The Efficacy and Safety of Inpegsomatropin Injection in Children With Idiopathic Short Stature
- Conditions
- Idiopathic Short Stature
- Interventions
- Drug: Inpegsomatropin Injection
- Registration Number
- NCT06927310
- Lead Sponsor
- Xiamen Amoytop Biotech Co., Ltd.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 300
- Prepubertal children: boys aged ≥3 years and <11 years at screening with testicular volume <4 mL; girls aged ≥3 years and <10 years at screening with breast development at Tanner Stage I, i.e., no palpable breast glandular tissue.
- Bone age ≤ chronological age,with a delay of no more than 2 years compared to chronological age.
- 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.
- Individuals with closed epiphyses;
- 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 have received inhaled corticosteroids for more than 2 consecutive weeks, or oral or intravenous corticosteroids for more than 1 week within 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 anemia, malnutrition, hypothyroidism, chronic kidney disease, cardiovascular diseases (e.g., congenital heart disease, dilated cardiomyopathy, etc.), psychiatric disorders, or those with congenital anomalies;
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Inpegsomatropin group Inpegsomatropin Injection - rhGH group Recombinant Human Growth Hormone Injection -
- Primary Outcome Measures
Name Time Method Growth velocity (HV, cm/year). Week 52
- Secondary Outcome Measures
Name Time Method Change in height standard deviation score from baseline (△HT SDS) From baseline to all follow-up time points at Week 52 Change in growth velocity from baseline (△HV) From baseline to all follow-up time points at Week 52 Change in insulin-like growth factor 1 standard deviation score from baseline (△IGF-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 (△BA/△CA) From baseline to all follow-up time points at Week 52
Related Research Topics
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Trial Locations
- Locations (17)
The Second Affiliated Hospital of Anhui Medical University
🇨🇳Hefei, Anhui, China
Capital Institute of Pediatrics, Beijing (SHOUER)
🇨🇳Beijing, Beijing, China
Children's Hospital of Chongqing Medical University
🇨🇳Chongqing, Chongqing, China
The First Affiliated Hospital of Xiamen University
🇨🇳Xiamen, Fujian, 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, 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