Clinical Study of Pegylated Somatropin (PEG Somatropin) to Treat SGA Children With Short Stature

The study was evaluated as the optimal dose for the treatment of SGA short stature children by Pegylated Somatropin, initially evaluated its efficiency and safety for the treatment of SGA short stature children and provided scientific, reliable basis for phase III clinical trials for dose selection. This is a multicenter, randomized, open-label, dose-response trial, including a 52-week main phase and an ongoing safety extension phase continuing until reaching near-adult height (NAH) in China. Ninety-six growth hormone (GH)-treatment-naïve, non-GH-deficient, prepubertal short children born SGA were randomized in a 1:1 ration to receive weekly subcutaneous administration of Jintrolong 0.1 mg/kg/week or 0.2 mg/kg/week for 52 weeks. Children who completed the 52- week main phase proceeded to the extension phase, while Jintrolong was administered at an initial dose of 0.2 mg/kg/week. Dose adjustments based on annualized height velocity (AHV) and insulin-like growth factor I (IGF-I) response, were made up to a maximum of 0.4 mg/kg/week until achieved NAH or the patient's voluntary discontinuation.

NCT Number	NCT02375620
Lead Sponsor	Changchun GeneScience Pharmaceutical Co., Ltd. Collaborators: Shanxi Provincial Maternity and Children's Hospital, Children's Hospital of Fudan University, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, The First Hospital of Jilin University, Hunan Children's Hospital, Tongji Hospital, Affiliated Hospital of Jiangnan University, Jiangxi Province Children's Hospital, Children's Hospital of The Capital Institute of Pediatrics
Conditions	Short Stature Children Born Small for Gestational Age (SGA)
Enrollment	96 participants
Start Date	2015-04-23
Primary Completion	2023-12-12 (estimated)
Study Completion	2025-12 (estimated)
Updated on ClinicalTrials.gov	2025-05-25