Benralizumab pregnancy exposure study

Study identifier:D3250R00026

ClinicalTrials.gov identifier:NCT03794999

EudraCT identifier:N/A

CTIS identifier:N/A

Terminated/Withdrawn

Official Title

The Benralizumab Pregnancy Exposure Study: A VAMPSS Post Marketing Surveillance Study

Medical condition

asthma

Phase

N/A

Healthy volunteers

Study drug

Benralizumab-exposure, Exposure to other asthma medications

Sex

Female

Actual Enrollment

299

Study type

Observational

Age

18 Years - 130 Years

Date

Study Start Date: 20 Mar 2019

Primary Completion Date: 29 Dec 2023

Study Completion Date: 29 Dec 2023

Study design

Allocation: N/A
Endpoint Classification: -
Intervention Model: -
Masking: -
Primary Purpose: -

Verification:

Verified 01 Apr 2024 by AstraZeneca

Collaborators

University of California, San Diego, Department of Pediatrics

Inclusion and exclusion criteria

Inclusion Criteria

- 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 Criteria:
- 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.
Exclusion Criteria:
- Women with exposure to benralizumab any time during pregnancy or within 8 weeks
prior to LMP.
- Women will not be eligible for Cohort 2 if they first come in contact with the OTIS
Research Center after prenatal diagnosis of a major structural birth defect.
- Retrospective cases (outcome of pregnancy known prior to enrollment).
- Women who have enrolled in the current study with a previous pregnancy.
Cohort 3: Non-Asthmatic Comparison
Inclusion Criteria:
- Currently pregnant women who contact the OTIS Research Center.
- Eligible women may potentially have been exposed to non-teratogenic agents during this
pregnancy.
- Women who agree to the conditions and requirements of the study including the interview
schedule and release of medical records.
Exclusion Criteria:
- Women who have been exposed to any known teratogenic agents as determined by the
OTIS Research Center (list in Annex 1) for any number of days, at any dose, from the
first day of the last menstrual period up to and including the end of pregnancy.
- Women with a self-reported diagnosis of asthma, current or previous.
- Women will not be eligible for Cohort 3 if they come in contact with the OTIS Research
Center after prenatal diagnosis of a major structural birth defect.
- Retrospective cases (outcome of pregnancy known prior to enrollment).
- Women who have enrolled in the current study with a previous pregnancy.

Exclusion Criteria

Cohort 1: Benralizumab-Exposed

No locations available

Arms	Assigned Interventions
Benralizumab-exposed group Pregnant women with asthma exposed to benralizumab anytime during pregnancy or within 8 weeks prior to last menstrual period	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).
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.	-

Documents available

Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

[email protected]

Investigators

Principal Investigator

Christina Chambers

University of California San Diego