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NOT YET RECRUITING
NCT07841678
PHASE3

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.

View on ClinicalTrials.gov

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

Interventions

DRUG

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.

DRUG

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