Condition: Small for Gestational Age · Sponsor: Xiamen Amoytop Biotech Co., Ltd.
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.
This description comes directly from the study's public registry record.
Xiaoping Luo, Ph.D · 15671671188 · xpluo@tjh.tjmu.edu.cn
Always discuss trial participation with your own doctor first.
| Beijing Children's Hospital, Capital Medical University | Beijing, China | Recruiting |
| Beijing Children's Hospital, Capital Medical University | Beijing, China | Recruiting |
| Peking Union Medical College Hospital, Chinese Academy of Medical Sciences | Beijing, China | Recruiting |
| The First Hospital of Jilin University | Changchun, China | Recruiting |
| Hunan Children's Hospital | Changsha, China | Recruiting |
| Chengdu Women's and Children's Central Hospital | Chengdu, China | Recruiting |
| West China Second University Hospital, Sichuan University | Chengdu, China | Recruiting |
| Children's Hospital of Chongqing Medical University | Chongqing, China | Recruiting |
| Fuzhou First General Hospital | Fuzhou, China | Recruiting |
| Guangzhou Women and Children's Medical Center, Guangzhou Medical University | Guangzhou, China | Recruiting |
| Sun Yat-sen Memorial Hospital, Sun Yat-sen University | Guangzhou, China | Recruiting |
| The First Affiliated Hospital of Sun Yat-sen University | Guangzhou, China | Recruiting |
+ 37 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT07309562