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

StatusActive, Not Recruiting
PhasePhase 2
Started
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Record History

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  1. Study sites: 7 to 12
    • Collaborators: 7 to 12
    v3
  2. Primary completion date: Dec 2022 to Jun 2030v2 Show 4 more changesShow less
    • Start date: Mar 29, 2017 to May 12, 2017
    • Trial status: Recruiting to Active, Not Recruiting
    • Study completion date: Jun 2026 to Jun 2030
    • Site details revised at 7 of 7 sites
  3. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
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.
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
(from sponsor)		 Dwarfism
Related terms Dwarfism
Enrollment 360 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov