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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DA-3031 | Experimental | PEG-G-CSF |
|
| Leucostim® | Active Comparator | G-CSF |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PEG-G-CSF | Drug | Prefilled syringe, 6mg/day, single dosing per cycle, for 6 cycle |
|
| Measure | Description | Time Frame |
|---|---|---|
| Duration of grade 4 neutropenia in cycle 1 | Grade 4 neutropenia means the ANC count is less than 500/mm3. | 21 day |
| Measure | Description | Time Frame |
|---|---|---|
| ANC nadir in cycle 1 | ANC nadir means the lowest point of ANC count. | 21 day |
| Time to ANC recovery in cycle 1 | ANC recovery means the ANC count is more than 2,000/mm3. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| JaeHong Seo, M.D. | Korea University Guro Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Korea University GURO hospital | Seoul | 152-703 | South Korea |
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| ID | Term |
|---|---|
| C486981 | pegylated granulocyte colony-stimulating factor, human |
| D016179 | Granulocyte Colony-Stimulating Factor |
| ID | Term |
|---|---|
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
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| G-CSF | Drug | Vial, 100ug/m2/day, multiple dosing per cycle(daily administration, up to 10 days), for 6 cycle |
|
|
| 21 day |
| Incidence of febrile neutropenia | Febrile neutropenia means the ANC count is less than 1,000/mm3 and body temperature is more than 38.3 degrees celsius. | 126 day |
| Incidence of IV antibiotics administration | IV antibiotics administration means that antibiotics are administered through intravenous route. | 126 day |
| D016298 |
| Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |