This is a multicenter, randomized, open-label, positive-controlled phase III confirmatory clinical study. A total of 84 children with short stature due to Turner Syndrome (TS) are planned to be enrolled. Stratified by age and karyotype, subjects will be randomized at a 1:1 ratio to either the test group or the positive control group with continuous treatment for 52 weeks. The study aims to compare the efficacy and safety of Inpegsomatropin-Injection versus Givopegsomatropin Solution Injection in children with TS-related short stature, so as to provide evidence for the new indication application of the investigational drug.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
84
Inpegsomatropin injection, 280 μg/kg/week, s.c., once weekly, for 52 weeks.
Givopegsomatropin Solution Injection, 200 μg/kg/week, s.c., once weekly, for 52 weeks.
Anyang Maternal and Child Health Hospital
Anyang, China
RECRUITINGBeijing Children's Hospital, Capital Medical University
Beijing, China
RECRUITINGCapital Institute of Pediatrics, Capital Medical University
Beijing, China
RECRUITINGPeking Union Medical College Hospital, Chinese Academy of Medical Sciences
Beijing, 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 height 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 change in bone age from baseline to change in chronological age from baseline (△BA/△CA)
Time frame: Week 52
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Peking University First Hospital
Beijing, China
RECRUITINGThe Second Xiangya Hospital of Central South University
Changsha, China
RECRUITINGChengdu Women's and Children's Central Hospital
Chengdu, China
RECRUITINGChildren's Hospital of Chongqing Medical University
Chongqing, China
RECRUITINGThe First Affiliated Hospital of Dalian Medical University
Dalian, China
RECRUITINGGuangdong Provincial Maternal and Child Health Hospital
Guangzhou, China
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