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PEG-rhGH in children born small for gestational age
NCT07260500Phase 2
Key facts
- Status
- Recruiting
- Start
- Nov 2025
- Primary completion
- Dec 2026
- Countries
- 1
- Modality
- Recombinant Proteins and Enzymes
- Drugs
- peg-somatropin
- Conditions
- short stature in children born small for gestational age (SGA-SS)
01
Overview
Phase 2, randomised, open-label trial of peg-somatropin in short stature in children born small for gestational age (SGA-SS) (3 arms), sponsored by Changchun GeneScience Pharmaceutical Co., Ltd. Primary endpoint: Annual Height Velocity at 26 weeks. Started Nov 2025; status: recruiting.
02
Design
3 arms- Study design
- RandomizedOpen-label
PEG-rhGH dose 1 weekly
Jintrolong dose 1 weekly for 26 weeks
PEG-rhGH dose 2 weekly
Jintrolong dose 2 weekly for 26 weeks
Daily hGH (active control)
Jintropin daily for 26 weeks
03
Who it enrols
Prepubertal children (>= 3 years) born full-term SGA with height > 2 SD below average, bone age not advanced, and no prior growth hormone treatment.
04
Endpoints
Primary
Annual Height Velocity
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