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

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

Recruiting
3 years and older
All
Phase 2

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Overview

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.

Eligibility

Inclusion Criteria:

  • Born full-term and "small-for-dates" - Born at 37-41 weeks (full-term). - Birth weight below the 10th percentile for that week of pregnancy and sex .
  • At least 3 years old on the day the parent signs the consent form.
  • Still prepubertal (Tanner stage I - no signs of puberty yet).
  • Height at the first study visit is more than 2 standard deviations below the average for his or her age and sex.
  • Bone age on X-ray is no more than 1 year ahead of real age.
  • Never taken growth hormone, IGF-1, or any ghrelin-like medicine before.
  • Child and parent/guardian are willing to sign the consent form and follow the study visits.

Exclusion Criteria:

  • Severe allergy to growth hormone or its ingredients.
  • Growth-hormone deficiency.
  • Any chromosome/genetic/syndrome cause of short stature.
  • Other diseases that can impair growth.
  • Cognitive, developmental, or psychiatric disorders that could affect assessments .
  • Current or past cancer, or high familial cancer risk.
  • Positive hepatitis B, hepatitis C, HIV, or active tuberculosis at screening.
  • Abnormal liver or kidney blood tests.
  • Pre-diabetes or diabetes at screening .
  • Systemic steroids \> 28 consecutive days or \> 14 days total in the last 3 months.
  • High-dose inhaled steroids \> 28 days in the last year.
  • Prior use of aromatase inhibitors, GnRH analogues, sex hormones, anabolic agents, or other drugs that affect growth. 13. Unable to receive subcutaneous injections.
  • Claustrophobia or inability to undergo brain MRI.
  • Participated in another clinical trial with investigational treatment within 3 months.
  • Any other condition that, in the investigator's opinion, makes the child unsuitable for the study.

Study details
    Short Stature Children Born Small for Gestational Age (SGA)

NCT07260500

Changchun GeneScience Pharmaceutical Co., Ltd.

1 February 2026

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