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A Phase III Clinical Study of Jinpei Growth Hormone Injection in the Treatment of Short Stature Children With Small for Gestational Age (SGA)
Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd.
Summary
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.
Official title: A Multicenter, Randomized, Open-Label, Active-Controlled Phase III Clinical Study to Evaluate the Efficacy, Safety and Pharmacokinetic Characteristics of Jinpei Growth Hormone Injection in the Treatment of Short Stature Children With Small for Gestational Age (SGA)
Key Details
Gender
All
Age Range
3 Years - Any
Study Type
INTERVENTIONAL
Enrollment
105
Start Date
2026-09
Completion Date
2030-01
Last Updated
2026-09-25
Healthy Volunteers
No
Conditions
Interventions
PEG-hGH Injection
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.
hGH Injection
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.
Locations (1)
Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology.
Wuhan, Hubei, China