The purpose of this study is to evaluate the efficacy and safety of weekly GenSci004 compared with daily Genotropin in treatment-naive children with growth failure due to GHD.
The purpose of this Phase 3 study is to evaluate the efficacy, safety, and tolerability of weekly GenSci004 compared to daily Genotropin over 52 weeks in prepubertal treatment-naïve children with growth failure due to GHD.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
162
GenSci004 is a pegylated rhGH (PEG rhGH) (i.e., PEG-somatropin)
Genotropin
Cook Childrens
Fort Worth, Texas, United States
Annualized Height Velocity (AHV) for GenSci004 and Genotropin groups
Measured in centimeter per year (cm/year)
Time frame: 52 weeks
Annualized Height Velocity (AHV) for GenSci004 and Genotropin groups
Measured in centimeter per year (cm/year)
Time frame: 104 weeks
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