Benralizumab Pregnancy Exposure Study

TerminatedOBSERVATIONAL
Enrollment

299

Participants

Timeline

Start Date

March 20, 2019

Primary Completion Date

December 29, 2023

Study Completion Date

December 29, 2023

Conditions
Asthma
Interventions
DRUG

Benralizumab-exposure

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).

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.

Trial Locations (1)

92103

Research Site, San Diego

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

University of California, San Diego

OTHER

lead

AstraZeneca

INDUSTRY