Clinical Trial: Phase III Study of DA-3031(PEG-G-CSF) in Chemotherapy-induced Neutropenia
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
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
Brief 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.
Detailed Summary: 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.
Sponsor: Dong-A ST Co., Ltd.
Current Primary Outcome: Duration of grade 4 neutropenia in cycle 1 [ Time Frame: 21 day ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- ANC nadir in cycle 1 [ Time Frame: 21 day ]ANC nadir means the lowest point of ANC count.
- Time to ANC recovery in cycle 1 [ Time Frame: 21 day ]ANC recovery means the ANC count is more than 2,000/mm3.
- Incidence of febrile neutropenia [ Time Frame: 126 day ]Febrile neutropenia means the ANC count is less than 1,000/mm3 and body temperature is more than 38.3 degrees celsius.
- Incidence of IV antibiotics administration [ Time Frame: 126 day ]IV antibiotics administration means that antibiotics are administered through intravenous route.
Original Secondary Outcome:
- ANC nadir in cycle 1 [ Time Frame: 21 day ]ANC nadir means the lowest point of ANC count.
- Time to ANC recovery in cycle 1 [ Time Frame: 21 day ]ANC recovery means the ANC count is more than 2,000/mm3.
- Incidence of febrile neutropenia [ Time Frame: 126 day ]Febrile neutropenia means the ANC count is less than 1,000/mm3 and body temparature is more than 38.3 degrees celsius.
- Incidence of IV antibiotics adminstration [ Time Frame: 126 day ]IV antibiotics adminstration means that antibiotics are administered through intravenous route.
Information By: Dong-A ST Co., Ltd.
Dates:
Date Received: January 19, 2012
Date Started: February 2012
Date Completion:
Last Updated: September 29, 2014
Last Verified: September 2014