To evaluate the safety and efficacy of PEG Somatropin Injection (Jintrolong®) in the treatment of short stature due to endogenous growth hormone deficiency (GHD) in the broad of population of children.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
900
High dose group: PEG Somatropin 0.2 mg/kg/w, subcutaneous use, inject once a week, the duration is for 26 weeks.
Low dose group: PEG Somatropin 0.14 mg/kg/w, subcutaneous use, inject once a week, the duration is for 26 weeks.
The Second Hospital of Anhui Medical University
Hefei, Anhui, China
The change of Height Standard Deviation Score for Chronological Age before and after the treatment (ΔHtSDSCA)
HtSDSCA = (Height at the evaluated time point- the mean value of normal children in the same gender and same age) / the height SD of normal children in the same gender and same age
Time frame: 26 weeks
HtSDSBA
HtSDSBA = (height at the evaluated time point-the mean value of normal children in the same gender and same age) / height SD of normal children in the same bone age and same gender
Time frame: 26 weeks
Annual height velocity
Annual Growth Velocity (cm/yr) = 12×(Height at the end of treatment-Height at the beginning of treatment)/the treatment duration (month)
Time frame: 26 weeks
Standard Deviation Score of serum IGF-1 (IGF-1 SDS)
IGF-1 SDS = (actual concentration of IGF-1-the median of IGF-1 concentration of normal children in the age and same gender) / SD of IGF-1 concentration of normal children in the same gender and same age
Time frame: 26 weeks
Bone Maturation
Bone Maturation = (BA at the end of treatment-BA at the beginning of treatment)/ the treatment duration (Year)
Time frame: 26 weeks
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