clinical trial · NCT03255694
A Study Extension Period of PEG-somatropin (Pegylated-somatropin) in the Treatment of Children With Idiopathic Short Stature
Changchun GeneScience Pharmaceutical Co., Ltd.·phase2·active not recruiting·n = 360
DwarfismPEG-somatropin
brief 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.
started
May 12, 2017
primary completion
Jun 1, 2030
completion
Jun 1, 2030
last updated
Aug 15, 2025
official title
A Phase 2 Study Extension Period of Pegylated Somatropin (PEG-somatropin) in the Treatment of Children With Idiopathic Short Stature: An Open, Non-controlled Observational Study.
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol