drugset / Trial / NCT06024967

A Study to Investigate the Safety and Efficacy of Once-weekly PEG-somatropin (GenSci004) in Children With Growth Hormone Deficiency

NCT06024967

Phase 3 Unknown 180 enrolled Changchun GeneScience Pharmaceutical Co., Ltd.
NaSingle-groupOpen-labelTreatment

Summary

The purpose of this Phase 3 study is to evaluate the safety and efficacy of once-weekly GenSci004 over 108 weeks in children with GHD aged from 6 months to 17 years old, inclusive.

Timeline

Start
2023-12-01
Primary completion
2025-05-01
Completion
2025-09-01

Drugs

EvaluationDrugModalityDoseRoute
Subject PEG-somatropin Protein / enzyme biologic

Indications

No indication recorded.