To Evaluate the safety and efficacy of PEG Somatropin in the treatment of children with growth hormone deficiency, as well as to study the dosage of PEG Somatropin.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
900
30IU/10 mg/3ml/kit, 0.1-0.2mg /kg/w, once per day for 26 weeks.
Ht SDSca (Height Standard Deviation Score for Chronological Age)
Ht SDSca was calculated by dividing the difference between the actual height of a patient and the mean height of the population for that chronological age by the standard deviation (SD) of the height of the population for that chronological age
Time frame: Baseline
Change of yearly growth velocity from baseline to 26 weeks
Height velocity calculate by formula
Time frame: Baseline, 26 weeks after initiating treatment
Ht SDSca
Ht SDSca was calculated by dividing the difference between the actual height of a patient and the mean height of the population for that chronological age by the standard deviation (SD) of the height of the population for that chronological age
Time frame: 26 weeks after initiating treatment
Ht SDSBA (Height Standard Deviation Score for Bone Age)
Time frame: Baseline,26 weeks after initiating treatment
IGF-1 SDS (IGF-1 Standard Deviation Score)
Time frame: Baseline,26 weeks after initiating treatment
IGFBP-3 SDS (IGFBP-3 Standard Deviation Score)
Time frame: Baseline,26 weeks after initiating treatment
Skeletal maturity
Skeletal maturity=(Bone Age at 26 weeks-Bone Age at baseline)/treatment duration
Time frame: Baseline,26 weeks after initiating treatment
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Anhui Provincial Children's Hospital
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