The study was evaluated as the optimal dose for the treatment of SGA short stature children by Pegylated Somatropin, initially evaluated its efficiency and safety for the treatment of SGA short stature children and provided scientific, reliable basis for phase III clinical trials for dose selection. This is a multicenter, randomized, open-label, dose-response trial, including a 52-week main phase and an ongoing safety extension phase continuing until reaching near-adult height (NAH) in China. Ninety-six growth hormone (GH)-treatment-naïve, non-GH-deficient, prepubertal short children born SGA were randomized in a 1:1 ration to receive weekly subcutaneous administration of Jintrolong 0.1 mg/kg/week or 0.2 mg/kg/week for 52 weeks. Children who completed the 52- week main phase proceeded to the extension phase, while Jintrolong was administered at an initial dose of 0.2 mg/kg/week. Dose adjustments based on annualized height velocity (AHV) and insulin-like growth factor I (IGF-I) response, were made up to a maximum of 0.4 mg/kg/week until achieved NAH or the patient's voluntary discontinuation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
96
Children's Hospital, Capital Institute of Pediatrics
Beijing, Beijing Municipality, China
Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology
Wuhan, Hubei, China
Hunan Children's Hospital
Changsha, Hunan, China
Affiliated Hospital of Jiangnan University
Wuxi, Jiangsu, China
Jiangxi Provincial Children's Hospital
Nanchang, Jiangxi, China
First Hospital of Jilin University
Changchun, Jilin, China
Children's Hospital of Fudan University
Shanghai, Shanghai Municipality, China
Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China
Shanxi Children's Hospital/Shanxi Women and Children Hospital
Taiyuan, Shanxi, China
The change in height standard deviation scores (HT SDS) of the chronological age from baseline.
Time frame: The main phase is at 52 weeks and the extension phase is at every 52 weeks up to study completion.
Annualized Height Velocity
Time frame: The main phase is at 52 weeks and the extension phase is at every 52 weeks up to study completion.
The change of height from baseline
Time frame: The main phase is at 52 weeks and the extension phase is at every 52 weeks up to study completion.
Bone maturity (bone age/ chronological age , △BA/△CA )
Time frame: The main phase is at 52 weeks and the extension phase is at every 52 weeks up to study completion.
The change of IGF-1 standard deviation scores(IGF-1 SDS) from baseline
Time frame: The main phase is at 52 weeks and the extension phase is at every 52 weeks up to study completion.
The change of mole ratio of IGF-1/IGFBP-3 from baseline
Time frame: The main phase is at 52 weeks and the extension phase is at every 52 weeks up to study completion.
The change of BMI standard deviation scores(BMI SDS)
Time frame: The main phase is at 52 weeks and the extension phase is at every 52 weeks up to study completion.
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