The Benralizumab Pregnancy Exposure Study: A VAMPSS Post Marketing Surveillance Study
Benralizumab-exposure, Exposure to other asthma medications
Endpoint Classification: -
Intervention Model: -
Primary Purpose: -
Verified 01 Nov 2023 by AstraZeneca
University of California, San Diego, Department of Pediatrics
No locations available
Pregnant women with asthma exposed to benralizumab anytime during pregnancy or within 8 weeks prior to last menstrual period
Exposure is defined as any dose of benralizumab for any length of time from 8 weeks prior to Last Mentrual Period (LMP) through the end of pregnancy, as reported by the mother and validated through medical record review. The 8-week cut-off prior to LMP is based upon the terminal half-life of benralizumab of approximately 15 days (clearance of benralizumab is based on five half-lives).
|Asthmatic comparison group
Pregnant women currently treated for asthma not exposed to benralizumab during pregnancy or within 8 weeks prior to last menstrual period
Drug: Exposure to other asthma medications
Exposure to asthma medications for any number of days, at any dose, and at any time from LMP up to the date of enrollment, but no exposure to benralizumab during pregnancy or within 8 weeks prior to LMP.
|Non-asthmatic comparison group
Pregnant women who are not diagnosed with asthma, have not had exposure to a known human teratogen, and have not taken benralizumab during pregnancy.