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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
105
PEGylated 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.
Recombinant 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.
Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology.
Wuhan, Hubei, China
Annualized Height Velocity (AHV)
Time frame: Week 52
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