Status:
TERMINATED
Benralizumab Pregnancy Exposure Study
Lead Sponsor:
AstraZeneca
Collaborating Sponsors:
University of California, San Diego
Conditions:
Asthma
Eligibility:
FEMALE
18-130 years
Brief Summary
This is a prospective, observational, exposure cohort study of pregnancy and infant outcomes in women with asthma exposed to benralizumab anytime during pregnancy, or within 8 weeks prior to the first...
Eligibility Criteria
Inclusion
- Participants will be recruited into the three cohorts concurrently, on the basis of the following inclusion/exclusion criteria:
- Cohort 1: Benralizumab-Exposed
- Currently pregnant women diagnosed with asthma who contact the OTIS Research Center and who have been exposed to benralizumab for any number of days, at any dose, and at any time from 8 weeks before the first day of LMP up to and including the end of pregnancy.
- Eligible participants will be currently pregnant women who agree to the conditions and requirements of the study including the interview schedule and release of medical records.
Exclusion
- Women who have had exposure to another biologic, used for any indication, anytime during pregnancy or within 8 weeks of LMP.
- Women will not be eligible for Cohort 1 if they first contact the OTIS Research Center after prenatal diagnosis of a major structural birth defect.
- Restrospective cases (outcome of pregnancy known prior to enrollment).
- Women who have enrolled in the current study with a previous pregnancy.
- Cohort 2: Treated Diseased Comparison
- Inclusion Criteria:
- Currently pregnant women diagnosed with asthma and exposed to asthma medications for any number of days, at any dose, and at any time from LMP up to the date of enrollment, who contact the OTIS Research Center but who were not exposed to benralizumab during pregnancy or within 8 weeks prior to LMP.
- Eligible participants will be currently pregnant women who agree to the conditions and requirements of the study including the interview schedule and release of medical records.
Key Trial Info
Start Date :
March 20 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 29 2023
Estimated Enrollment :
299 Patients enrolled
Trial Details
Trial ID
NCT03794999
Start Date
March 20 2019
End Date
December 29 2023
Last Update
November 22 2024
Active Locations (1)
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1
Research Site
San Diego, California, United States, 92103