The Efficacy and Safety of Inpegsomatropin Injection in Children With Turner Syndrome (TS) and Short Stature

Recruiting Phase 3 Interventional Study
Turner Syndrome
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
2 – 12
Sex
Female
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
84 (estimated)
Sponsor
Xiamen Amoytop Biotech Co., Ltd. · Industry
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About This Trial
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…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Prepubertal girls at Tanner stage I, with age ≥ 2 years and \< 12 years at the time of informed consent signature. * With clinical manifestations of Turner syndrome and a confirmed diagnosis of Turner syndrome based on peripheral blood karyotype analysis (karyotype analysis of…
Contacts

Xiaoping Luo

15671671188

xpluo@tjh.tjmu.edu.cn

CONTACT