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

Chemotherapy Induced Neutropenia Clinical Trial

Official title: Randomized, Open, Multi-Center, Phase III Study to Evaluate Efficacy and Safety in Chemotherapy-induced Neutropenia of Once-per-cycle DA-3031(PEG-G-CSF) and Daily G-CSF in Patients With Malignancies Receiving Myelosuppressive Chemotherapy

Status Completed

Clinical Trial Summary

This study is to determine whether once-per-cycle DA-3031(PEG-G-CSF) is not inferior to daily G-CSF in chemotherapy-induced neutropenia.

Clinical Trial Description

Eligible subjects are randomly assigned to receive once-per-cycle DA-3031(PEG-G-CSF) or daily G-CSF(up to 10 days). This study is conducted for 6 cycles of chemotherapy, that each cycle is repeated every 21 days. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chemotherapy Induced Neutropenia
• Neutropenia

• NCT number: NCT01674855
• Study type: Interventional
• Source: Dong-A ST Co., Ltd.
• Status: Completed
• Phase: Phase 3
• Start date: February 2012
• Completion date: May 2013