To evaluate the safety and efficacy of PEG Somatropin Injection in the treatment of children with growth hormone deficiency, as well as to study the feasibility of extending the dosing intervals (once per two weeks) of PEG Somatropin Injection.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
600
Pegylated somatropin, injection, 54IU/9.0mg/1.0ml/bottle Group of dosing per week:0.20 mg /kg/w, once per week for 26 weeks
Pegylated somatropin, injection, 54IU/9.0mg/1.0ml/bottle Group of dosing per two weeks:0.20 mg /kg/2w,once per two weeks for 26 weeks
Maternal and Child Health Hospital of Anhui province
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: Baseline, 4,12,26 weeks after initiating treatment
Ht SDSBA
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Time frame: Baseline, 4,12,26 weeks after initiating treatment
Yearly growth velocity
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Time frame: Baseline, 4,12,26 weeks after initiating treatment
IGF-1SDS
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Time frame: Baseline, 4,12,26 weeks after initiating treatment
IGF-1/IGFBP-3 molar ratio
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Time frame: Baseline, 4,12,26 weeks after initiating treatment
Bone age
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Time frame: Baseline, 4,12,26 weeks after initiating treatment
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Hefei, Anhui, China
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Lu'an, Anhui, China
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