drugset / Trial / NCT03290235

Extension Study of Pegylated Somatropin to Treat Growth Retardation Caused by Endogenous Growth Hormone Deficiency in Children

NCT03290235

Phase 4 Unknown 1500 enrolled Changchun GeneScience Pharmaceutical Co., Ltd.
Non-randomizedParallel-groupOpen-labelTreatment

Summary

1. To further evaluate the safety and efficacy of PEG-Somatropin in the treatment of children with growth hormone deficiency for a relatively long period 2. To explore the factors influencing the efficacy of PEG-Somatropin and to establish the height prediction model based on Chinese children with short stature, and to provide the basis and guidance for standard and reasonable long-term clinical application of PEG-Somatropin.

Timeline

Start
2017-03-01
Primary completion
2020-10
Completion
2021-09

Drugs

EvaluationDrugModalityDoseRoute
Subject PEG-somatropin Protein / enzyme biologic 0.1 mg/kg Other
Subject PEG-somatropin Protein / enzyme biologic 0.2 mg/kg Other

Indications

No indication recorded.