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 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.
• 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.