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

StatusActive, Not Recruiting
PhasePhase 2
Started
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Record History

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  1. Primary completion date changed from estimate of Jul 2017 to Dec 12, 2023v2 Show 10 more changesShow less
    • Start date: Oct 2014 to Apr 23, 2015
    • Primary endpoint revised
    • Trial status: Recruiting to Active, Not Recruiting
    • Study sites: 7 to 9
    • Study completion date: Dec 2017 to Dec 2025
    • Eligibility criteria expanded, about 205 words
    • Secondary endpoints: 3 to 6
    • Study description shortened, about 25 words
    • Collaborators: 5 to 9
    • Study arms: 2 to 3
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
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
(from sponsor)		 Short Stature Children Born Small for Gestational Age (SGA)
Enrollment 96 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov