PEG-rhGH versus hGH injections for short children born small for gestational age
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)
This test will see if weekly PEG-rhGH injections or daily hGH injections help prepubertal children born small for gestational age grow taller.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 72 (estimated) |
| Ages | 3 Years and up |
| Sex | All |
| Sponsor | Changchun GeneScience Pharmaceutical Co., Ltd. Industry-sponsored |
| Locations | 1 site (Wuhan, Hubei) |
| Trial ID | NCT07260500 on ClinicalTrials.gov |
What this trial studies
This multi-center Phase 2 trial enrolls prepubertal children born small for gestational age and runs a 4-week run-in, a 26-week treatment period, and a 4-week follow-up. Participants are randomized into three groups: two different doses of PEG-rhGH (a long-acting, PEGylated recombinant growth hormone) and a standard daily hGH injection. The trial measures growth outcomes, safety events, and pharmacokinetics to compare efficacy and drug exposure between regimens. Eligible children are at least 3 years old, born full-term with birth weight below the 10th percentile, have height below -2 SD, and have not previously received growth hormone or IGF-1 therapy.
Who should consider this trial
Good fit: Ideal candidates are prepubertal children aged three years or older who were born full-term SGA, have height more than 2 standard deviations below the mean, have bone age no more than one year ahead, and have never received growth hormone or IGF-1 therapy.
Not a fit: Children who have already started puberty, have prior growth hormone or IGF-1 exposure, have markedly advanced bone age, or whose short stature has causes other than being born SGA are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the PEG-rhGH regimen could increase growth rate and improve convenience compared with daily hGH for children born SGA.
How similar studies have performed: Previous trials of long-acting PEGylated growth hormone have shown growth results comparable to daily hGH in pediatric populations, so this approach is supported by prior data rather than entirely novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Wuhan, Hubei
- Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology — Wuhan, Hubei, China (Recruiting)
Study contacts
- Study coordinator: Xiao Ping Luo
- Email: xpluo888@sina.com
- Phone: +8613387522645
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.