Condition: Turner Syndrome · Sponsor: Xiamen Amoytop Biotech Co., Ltd.
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.
This description comes directly from the study's public registry record.
Xiaoping Luo · 15671671188 · xpluo@tjh.tjmu.edu.cn
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| Anyang Maternal and Child Health Hospital | Anyang, China | Recruiting |
| Beijing Children's Hospital, Capital Medical University | Beijing, China | Recruiting |
| Capital Institute of Pediatrics, Capital Medical University | Beijing, China | Recruiting |
| Peking Union Medical College Hospital, Chinese Academy of Medical Sciences | Beijing, China | Recruiting |
| Peking University First Hospital | Beijing, China | Recruiting |
| The Second Xiangya Hospital of Central South University | Changsha, China | Recruiting |
| Chengdu Women's and Children's Central Hospital | Chengdu, China | Recruiting |
| Children's Hospital of Chongqing Medical University | Chongqing, China | Recruiting |
| The First Affiliated Hospital of Dalian Medical University | Dalian, China | Recruiting |
| Guangdong Provincial Maternal and Child Health Hospital | Guangzhou, China | Not Yet 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 |
+ 39 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT07614152