This study aims to explore the optimal dose of pegylated recombinant human growth hormone (PEG-rhGH) injection to treat children with idiopathic short stature (ISS), evaluate its safety and efficacy, and provide scientific and reliable evidence for the medication dosage in Phase III clinical study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
360
PEG-somatropin 0.1mg/kg/wk by weekly subcutaneous injection for 52 weeks.
PEG-somatropin 0.2 mg/kg/wk by weekly subcutaneous injection for 52 weeks.
Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, China
RECRUITINGThe First Affiated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China
RECRUITINGAffiliated Hospital of Jiangnan University
Wuxi, Jiangsu, China
Change in Height Standard Deviation Score for Chronological Age (ΔHtSDSCA)
Change in Height Standard Deviation Score for Chronological Age (ΔHtSDSCA) from Baseline to 52 weeks;ΔHtSDSCA=(height Yx - reference mean for CA Yx) / reference SD for CA Yx (Yx refers to the height value at particular timepoint x)
Time frame: Baseline,52 weeks
Change in Annualized Height Velocity
Annualized Height Velocity=12×(Height Yx - Height at Baseline)/(Date of Yx - Date of Baseline) (Yx refers to the height value at particular timepoint x)
Time frame: Baseline,52 weeks
Change in Bone Maturation
Bone Maturation=(BA Yx-BA at Baseline)/(Date of Yx - Date of Baseline) (Yx refers to the BA value at particular timepoint x)
Time frame: Baseline,52 weeks
Change in IGF-1 Standard Deviation Score (IGF-1 SDS)
GF-1 SDS=(IGF-1 Yx - reference mean for CA Yx) / reference SD for CA Yx (Yx refers to the IGF-1 value at particular timepoint x)
Time frame: Baseline,52 weeks
IGF-1/IGFBP-3 molar ratio at 52 weeks
IGF-1/IGFBP-3 molar ration=\[IGF-1(ng/ml)/7.6\]/\[IGFBP-3 (ng/ml)/25.75\]
Time frame: Baseline,52 weeks
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The First Hospital of Jilin University
Changchun, Jilin, China
RECRUITINGThe Children's Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
RECRUITINGShanghai Children's Hospital of Fudan University
Shanghai, China
RECRUITINGShanghai Children's Hospital
Shanghai, China
RECRUITING