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A Phase II Study of PEG-rhGH Injection for Short Children Born Small for Gestational Age: Efficacy, Safety, and Pharmacokinetics

StatusRecruiting
PhasePhase 2
Started
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Record History

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  1. Primary completion date: Oct 26, 2026 to Dec 23, 2026
    • Study completion date: Jan 31, 2027 to Apr 30, 2027
    • Eligibility criteria expanded, about 58 words
    v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This study will take place at multiple sites and is divided into three phases:an initial 4-week getting-to-know-you phase,a 26-week main phase where participants receive medication,and a 4-week follow-up phase.Participants will be divided into three groups:two will receive different doses of PEG-rhGH Injection,and the third will receive hGH Injection.The goal is to determine which medication works best.
Trial Details
NCT Number NCT07260500
Lead Sponsor Changchun GeneScience Pharmaceutical Co., Ltd.
Conditions
(from sponsor)		 Short Stature Children Born Small for Gestational Age (SGA)
Enrollment 72 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov