drugset / Trial / NCT02005458

Safety and Efficacy of YPEG-rhG-CSF in Cancer Patients Receiving Chemotherapy

NCT02005458 ↗

Phase 2 Completed 80 enrolled Xiamen Amoytop Biotech Co., Ltd.
RandomizedParallel-groupOpen-labelTreatment

Summary

This study is to examine which dose of YPEG-rhG-CSF, once-per-cycle, has similar efficacy and safety, comparing to PEG-rhG-CSF, once-per-cycle, in chemotherapy-induced neutropenia

Timeline

Start
2013-12
Primary completion
2017-03
Completion
2018-02

Drugs

EvaluationDrugModalityDoseRoute
Comparator PEG-rhG-CSF Protein / enzyme biologic 100 ug/kg Subcutaneous
Subject YPEG-rhG-CSF Unknown 20 ug/kg Subcutaneous
Subject YPEG-rhG-CSF Unknown 30 ug/kg Subcutaneous
Subject YPEG-rhG-CSF Unknown 45 ug/kg Subcutaneous