drugset / Trial / NCT07260500

A Phase II Study of PEG-rhGH Injection for Short Children Born Small for Gestational Age: Efficacy, Safety, and Pharmacokinetics

NCT07260500

Phase 2 Recruiting 72 enrolled Changchun GeneScience Pharmaceutical Co., Ltd.
RandomizedParallel-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2025-11-11
Primary completion
2026-12-23
Completion
2027-04-30

Drugs

EvaluationDrugModalityDoseRoute
Subject PEG-rhGH Protein / enzyme biologic Subcutaneous
Comparator hGH Protein / enzyme biologic Subcutaneous