drugset / Trial / NCT01923545

Phase II Study of DA-3031(PEG-G-CSF) in Chemotherapy-induced Neutropenia

NCT01923545

Phase 2 Completed 61 enrolled Dong-A ST Co., Ltd.
RandomizedParallel-groupOpen-labelTreatment

Summary

This study is to examine which dose of DA-3031(PEG-G-CSF) has similar efficacy and safety compared to daily G-CSF in chemotherapy-induced neutropenia.

Timeline

Start
2010-07
Primary completion
2011-05
Completion
2011-05

Drugs

EvaluationDrugModalityDoseRoute
Comparator G-CSF Unknown 100 ug/m2
Subject Pegfilgrastim Protein / enzyme biologic 3.6 mg
Subject Pegfilgrastim Protein / enzyme biologic 6 mg

Indications