Phase III Study of DA-3031(PEG-G-CSF) in Chemotherapy-induced Neutropenia (PEG-G-CSF)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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|
|Actual Primary Completion Date :||February 2013|
|Actual 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|