This is a multicenter, randomized, open-label, active-controlled Phase III clinical trial to evaluate the efficacy and safety of Inpegsomatropin injection,once a week,compared with recombinant human growth hormone (rhGH) in children with short stature born small for gestational age (SGA).It plans to enroll 141 children with short stature born small for gestational age (SGA), who will be stratified by gender and age and randomized in a 1:1:1 ratio to either Experimental Group 1, Experimental Group 2, or the Active Control Group. All participants will undergo a screening period (up to 12 weeks), a treatment period (52 weeks), and a post-treatment follow-up period (5 weeks). Safety and efficacy will be comprehensively evaluated.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
141
Inpegsomatropin injection, 140 μg/kg/week, s.c., once weekly, for 52 weeks.
Inpegsomatropin injection, 280 μg/kg/week, s.c., once weekly, for 52 weeks.
Recombinant human growth hormone injection, 0.033mg/kg/day, s.c.,once daily, for 52 weeks.
Beijing Children's Hospital, Capital Medical University
Beijing, China
Beijing Children's Hospital, Capital Medical University
Beijing, China
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Beijing, China
The First Hospital of Jilin University
Changchun, China
Hunan Children's Hospital
Changsha, China
Growth velocity (HV, cm/year).
Time frame: Week 52
Change in height standard deviation score from baseline (△HT SDS)
Time frame: From baseline to all follow-up time points at Week 52
Change in growth velocity from baseline (△HV)
Time frame: From baseline to all follow-up time points at Week 52
Change in insulin-like growth factor 1 standard deviation score from baseline (△IGF-1 SDS)
Time frame: From baseline to all follow-up time points at Week 52
Ratio of the change in bone age to the change in chronological age
Time frame: Week 52
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Chengdu Women's and Children's Central Hospital
Chengdu, China
West China Second University Hospital, Sichuan University
Chengdu, China
Children's Hospital of Chongqing Medical University
Chongqing, China
Guangzhou Women and Children's Medical Center, Guangzhou Medical University
Guangzhou, China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, China
...and 38 more locations