This is a multicenter, randomized, open-label, active-controlled Phase III clinical study to evaluate the efficacy, safety and pharmacokinetic (PK) characteristics of once-weekly PEG-hGH injection compared with once-daily hGH injection in the treatment of prepubertal children with short stature due to small for gestational age (SGA) who have not received prior growth hormone treatment.
Eligible subjects will be randomized in a 2:1 ratio to receive either PEG-hGH injection 0.3 mg/kg/week (experimental group) or hGH injection 0.066 mg/kg/day (active comparator group) for 52 weeks, followed by a 52-week extension period in which all subjects receive PEG-hGH injection 0.3 mg/kg/week. The primary endpoint is annualized height velocity (AHV) at Week 52.
Clinical diagnosis of small for gestational age (SGA), with birth certificate or discharge record; gestational age ≥28 weeks; birth weight and/or length below the 10th percentile (P10) for sex and gestational age.
Age ≥3 years at the time of informed consent (calculated from birth date on birth certificate/ID).
Prepubertal boys and girls (Tanner stage I).
Screening height < -2 SD of normal height reference values for same sex and chronological age.
Hypersensitivity to growth hormone class drugs or their excipients.
Suspected or confirmed pediatric growth hormone deficiency (GHD) requiring GH stimulation testing (GH peak >7 ng/mL excludes GHD).
Known chromosomal or gene mutations affecting growth, or known syndromes including but not limited to GHD, Turner syndrome, Laron syndrome, Noonan syndrome, Prader-Willi syndrome, Silver-Russell syndrome, skeletal dysplasia, SHOX gene abnormalities.
Any known or suspected disease/condition that may cause short stature and may interfere with endpoint evaluation, including but not limited to chronic kidney disease, diabetes, skeletal dysplasia (with family history), severe spinal abnormalities, malnutrition, hypothyroidism, immunodeficiency.
Parallel
PEG-hGH Injection
DrugPEGylated recombinant human growth hormone (PEG-hGH) injection, trade name Jinsizeng. Dose: 0.3 mg/kg/week, subcutaneous injection, once weekly. Specification: 54 IU/9.0 mg/1.0 mL/vial. Administered via electronic pen injector.
hGH Injection
DrugRecombinant human growth hormone (hGH) injection, trade name Saizeng. Dose: 0.066 mg/kg/day, subcutaneous injection, once daily. Specification: 30 IU/10 mg/3 mL/vial. Administered via electronic pen injector.
Annualized Height Velocity (AHV)
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