A Study Extension Period of PEG-somatropin (Pegylated-somatropin) in the Treatment of Children With Idiopathic Short Stature

• Status: ACTIVE_NOT_RECRUITING
• Trial end date: 2030-06-01

Summary

After the first stage (52 weeks) of Phase II clinical trial, Pegylated recombinant human growth hormone (PEG-rhGH) injection of appropriate dose in compliance with ISS clinical treatment strategy is used to treat children with ISS (Idiopathic Short Stature). The long-term efficacy and safety of the investigational product are evaluated, which can provide more scientific and reliable medication guidance information for clinical diagnosis and treatment.

• Phase: PHASE2

Details

• Lead Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd.
• Collaborators: Affiliated Hospital of Jiangnan University; Beijing Children's Hospital; Children's Hospital of Fudan University; Children's Hospital of Soochow University; Hunan Children's Hospital; Jiangxi Province Children's Hospital; Shanghai Children's Hospital; The Children's Hospital of Zhejiang University School of Medicine; The First Affiliated Hospital with Nanjing Medical University; The First Hospital of Jilin University; Tongji Hospital; Wuxi Women's & Children's Hospital