Comparable efficacy and safety profiles of daily injection of BK0023 and filgrastim (Neupogen®) in chemotherapy-induced neutropenia: a multinational, multicenter, investigator blind, randomised, parallel group study in women with breast cancer
- Registry ID
- EUCTR2007-007161-20
- Source registry
- EUCTR
- Status
- Ongoing
- Phase
- PHASE3
- Sponsor
- BIO-KER S.R.L
- Start date
- 2008-12-23
- Last update
- 2026-08-16
Conditions
- Chemotherapy induced Neutropenia
Summary
• To compare the efficacy of BK0023 to Neupogen® with respect to the duration of grade 4 neutropenia, defined as the number of days in which the subjects have an ANC < 0.5 x 109/L, mainly during the 1st chemotherapy cycle, assuming an equivalence range of -1 day, + 1 day.
Locations
- , , Bulgarian Drug Agency
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