Condition: Idiopathic Short Stature · 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 idiopathic short stature (ISS). It plans to enroll 300 children with ISS, who will be randomized , stratified by gender and age, and assigned to either the experimental group or the positive controlled group. Each participant will undergo a screening period (up to 12 weeks), a treatment period (52 weeks), and a post-treatment follow-up period (5 weeks). And the safety and efficacy will be 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.
| Anhui Provincial Children's Hospital | Hefei, Anhui, China | Recruiting |
| The Second Affiliated Hospital of Anhui Medical University | Hefei, Anhui, China | Recruiting |
| Capital Institute of Pediatrics, Beijing (SHOUER) | Beijing, Beijing Municipality, China | Recruiting |
| Children's Hospital of Chongqing Medical University | Chongqing, Chongqing Municipality, China | Recruiting |
| The First Affiliated Hospital of Xiamen University | Xiamen, Fujian, China | Recruiting |
| Gansu Provincial Maternity and Child Care Hospital | Lanzhou, Gansu, China | Recruiting |
| Guangzhou Women and Children's Medical Center | Guangzhou, Guangdong, China | Recruiting |
| Sun Yat-sen Memorial Hospital, Sun Yat-sen University | Guangzhou, Guangdong, China | Recruiting |
| The Third Affiliated Hospital, Sun Yat-sen University | Guangzhou, Guangdong, China | Recruiting |
| Henan Children's Hospital Zhengzhou Children's Hospital | Zhengzhou, Henan, China | Recruiting |
| Wuhan Children's Hospital | Wuhan, Hubei, China | Recruiting |
| Hunan Children's Hospital | Changsha, Hunan, China | Recruiting |
+ 26 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT06927310