This is a multicenter, randomized, open-labeled, positive controlled phase 2\&3 combined study to evaluate the safety and efficacy of weekly Y-shape pegylated somatropin, compared to daily somatropin (Norditropin®), in prepubertal, treatment-naive children with growth hormone deficiency.
This multicenter, randomized, open-labeled, positive controlled study is divided into two stages. The first one is aimed to exploit the optimal dose of Y-shape pegylated somatropin, while the second one is aimed to confirm the efficacy and safety of the study drug. A total of 400 prepubertal children with growth hormone deficiency were expected to enrolled. Subjects will firstly undergo a 52 weeks treatment, and then followed for 5 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
434
Y-shape pegylated somatropin 100μg/kg, subcutaneous injection, Once weekly.
Y-shape pegylated somatropin 120μg/kg, subcutaneous injection, Once weekly.
Y-shape pegylated somatropin 140μg/kg, subcutaneous injection, Once weekly.
Tongji Hospital, Tongji Medical College of HUST
Wuhan, Hubei, China
Phase 2: Change of areas under the curve of IGF-1 concentration from baseline (ΔIGF-1 AUC).
Time frame: 12 weeks
Phase 3: Height velocity.
Time frame: 52 weeks
Change of height standard deviation score according to chronological age.
Time frame: 52 weeks
Change of height standard deviation score according to bone age.
Time frame: 52 weeks
Serum IGF-l level
Time frame: change from baseline to 52 weeks
Serum IGFBP-3 level
Time frame: change from baseline to 52 weeks
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Norditropin 245μg/kg/week, subcutaneous injection, Once daily.
Y-shape pegylated somatropin 140μg/kg, subcutaneous injection, Once weekly.
Norditropin 245μg/kg/week, subcutaneous injection, Once daily.