Clinical Trial

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

Active, Not Recruiting Phase 2
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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.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2017-08-16; most recent amendment 2025-08-12.
Status change: Recruiting → Active, Not Recruiting 2023-06-21
Trial Details
NCT Number NCT03255694
Lead Sponsor Changchun GeneScience Pharmaceutical Co., Ltd.
Collaborators: Tongji Hospital, The First Hospital of Jilin University, Affiliated Hospital of Jiangnan University, The First Affiliated Hospital with Nanjing Medical University, Shanghai Children's Hospital, The Children's Hospital of Zhejiang University School of Medicine, Children's Hospital of Fudan University, Jiangxi Province Children's Hospital, Hunan Children's Hospital, Beijing Children's Hospital, Children's Hospital of Soochow University, Wuxi Women's & Children's Hospital
Conditions Dwarfism
Enrollment 360 participants
Start Date 2017-05-12
Primary Completion 2030-06 (estimated)
Study Completion 2030-06 (estimated)
Updated on ClinicalTrials.gov 2025-08-15