NCT05838885

A Trial of YPEG-rhGH in Children With Short Stature

A Multicenter, Randomized, Open-label, Positive-controlled Phase 2 Study to Explore the Optimal Dose of Y- Shaped Pegylated Recombinant Growth Hormone (YPEG-rhGH) in Children With Short Stature (ISS, SGA, TS)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 78 (actual)
• Sponsor: Xiamen Amoytop Biotech Co., Ltd. · Industry
• Sex: All
• Age: 4 Years – 11 Years
• Healthy volunteers: Not accepted

Summary

To explore the dose-response relationship between pharmacokinetics and pharmacodynamics of Y- Shaped Pegylated growth hormone injection (YPEG-GH) in children with short stature (idiopathic short stature (ISS), small for gestational age (SGA), Turner syndrome (TS)). To evaluate its tolerability, safety and efficacy and to provide evidence for dose selection and titration for future clinical development and clinical application in these population.

Conditions

• Idiopathic Short Stature
• Small for Gestational Age
• Turner Syndrome

Interventions

Type	Name	Description
DRUG	YPEG-rhGH	YPEG-rhGH, 140μg/kg, s.c., once a week, for 52 weeks
DRUG	YPEG-rhGH	YPEG-rhGH, 280μg/kg, s.c., once a week, for 52 weeks
DRUG	rhGH	rhGH, 245μg/kg/week, divided into 7 subcutaneous injections, once daily, for 52 weeks
DRUG	rhGH	rhGH, 470μg/kg/week, divided into 7 subcutaneous injections, once daily, for 52 weeks

Timeline

• Start date: 2022-02-15
• Primary completion: 2023-10-23
• Completion: 2023-12-19
• First posted: 2023-05-03
• Last updated: 2024-01-24

Locations

19 sites across 1 country: China