Phase III Study of DA-3031(PEG-G-CSF) in Chemotherapy-induced Neutropenia (PEG-G-CSF)
|ClinicalTrials.gov Identifier: NCT01674855|
Recruitment Status : Completed
First Posted : August 29, 2012
Last Update Posted : October 1, 2014
|Condition or disease||Intervention/treatment||Phase|
|Chemotherapy Induced Neutropenia||Drug: PEG-G-CSF Drug: G-CSF||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||74 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||February 2012|
|Primary Completion Date :||February 2013|
|Study Completion Date :||May 2013|
Prefilled syringe, 6mg/day, single dosing per cycle, for 6 cycle
Other Name: DA-3031
Active Comparator: Leucostim®
Vial, 100ug/m2/day, multiple dosing per cycle(daily administration, up to 10 days), for 6 cycle
Other Name: Leucostim®
- Duration of grade 4 neutropenia in cycle 1 [ Time Frame: 21 day ]Grade 4 neutropenia means the ANC count is less than 500/mm3.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01674855
|Korea, Republic of|
|Korea University GURO hospital|
|Seoul, Korea, Republic of, 152-703|
|Principal Investigator:||JaeHong Seo, M.D.||Korea University Guro Hospital|