The Efficacy and Safety of Inpegsomatropin Injection in Children With Short Stature Born Small for Gestational Age
Recruiting
Phase 3
Interventional Study
Small for Gestational Age
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.
At a Glance
- Age
- 2 – 11
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 141 (estimated)
- Sponsor
- Xiamen Amoytop Biotech Co., Ltd. · Industry
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About This Trial
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…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Prepubertal (Tanner stage I) children: boys aged ≥2 and \<11 years, and girls aged ≥2 and \<10 years at screening.
* Bone age is not more than 1 year advanced or more than 2 years delayed compared to chronological age (i.e., -2 years ≤ bone age - chronological age ≤ 1 year).
*…
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