1. To further evaluate the safety and efficacy of PEG-Somatropin in the treatment of children with growth hormone deficiency for a relatively long period 2. To explore the factors influencing the efficacy of PEG-Somatropin and to establish the height prediction model based on Chinese children with short stature, and to provide the basis and guidance for standard and reasonable long-term clinical application of PEG-Somatropin.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,500
Pegylated somatropin, injection, 54IU/9.0mg/1.0ml/kit
TongJi hospital affiliated to TongJi medical college of HuaZhong university of Science & Teconology
Wuhan, Hubei, China
RECRUITINGHt SDSca (Height standard deviation score for chronological age)
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, every 13 weeks until 130 weeks
Ht SDSBA (Height standard deviation score for bone age)
Time frame: Baseline, every 13 weeks until 130 weeks
Yearly growth velocity
Time frame: Baseline, every 13 weeks until 130 weeks
IGF-1 SDS (Standard deviation score of insulin-like growth factor-1)
Time frame: Baseline, every 13 weeks until 130 weeks
Bone age
Time frame: Baseline, 26 weeks, 52 weeks, 78 weeks, 104 weeks, 130 weeks
Near final height for some subjects
When yearly growth velocity of some subject is no more than 2cm/year.
Time frame: Baseline, every 13 weeks until 130 weeks
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