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Recruiting NCT07260500

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

Phase II Interventional Short Stature Children Born Small for Gestational Age (SGA)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: PEG-rhGH Injection, hGH Injection.
Who it may be relevant to
Registry conditions: Short Stature Children Born Small for Gestational Age (SGA). Basic parameters: from 3 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase II, Multicenter, Randomized, Open-label, Active-controlled Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Polyethylene Glycol Recombinant Human Growth Hormone Injection in Short Children Born Small for Gestational Age (SGA)

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.

Interventions

  • Drug PEG-rhGH Injection
    Jintrolong® Dose 1, subcutaneous injection, once weekly for 26 weeks for 24 subjects.. Jintrolong® Dose 2, subcutaneous injection, once weekly for 26 weeks for 24 subjects..
  • Drug hGH Injection
    Jintropin® dose 3, subcutaneous injection, once daily for 26 weeks (active comparator) for 24 subjects.

Primary outcome measures

  • Annual height velocity at Week 26 of treatment [Time frame: 26 Weeks]

Eligibility criteria

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.
  • Both the subject and their guardian are able to voluntarily sign the Informed Consent Form (ICF) and voluntarily cooperate in completing the trial according to the protocol. If the subject is legally incompetent, written informed consent from their guardian shall be obtained. Additionally, relevant information about the clinical trial shall be communicated to the subject within their understanding, and the subject should be encouraged to sign the ICF personally as much as possible.

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and — Wuhan

Identifiers

NCT: NCT07260500 · GenSci031-202

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗