Benralizumab Pregnancy Exposure Study

NCT ID: NCT03794999

Last Updated: 2024-11-22

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 299 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-03-20
• Study Completion Date: 2023-12-29

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 day of the last menstrual period (LMP)

The objective of the study is to monitor planned or unplanned pregnancies to evaluate potential teratogenic effect (birth defect) when exposed to benralizumab compared to two unexposed comparator groups.

The primary outcome is major structural birth defects (abnormalities in development of structures of the body) and the secondary outcomes are preterm delivery (premature baby), small for gestational age infants (small for weight, length, and/or head circumference), spontaneous abortion (miscarriage), stillbirth (baby born without signs of life), elective termination (voluntary abortion) and small for age postnatal growth to one year of age (small for weight, length and/or head circumference). The birth prevalence or incidence of outcomes in women exposed to benralizumab, and their infants, will be compared to those observed in two unexposed comparator groups: a disease-matched comparison group of women who have not used benralizumab during pregnancy or within 8 weeks of their last menstrual period (LMP), but who have used other anti-asthmatic medications (treated disease comparison group), and a comparison group of healthy women who do not have a diagnosis of asthma, have not had exposure to a known human teratogen (substance that causes birth defect), and have not taken benralizumab in pregnancy (healthy comparison group).

Conditions

Asthma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Benralizumab-exposed group

Pregnant women with asthma exposed to benralizumab anytime during pregnancy or within 8 weeks prior to last menstrual period

Benralizumab-exposure

Intervention Type: DRUG

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

Exposure to other asthma medications

Intervention Type: DRUG

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.

No interventions assigned to this group

Interventions

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).

Intervention Type: 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.

Intervention Type: DRUG

Eligibility 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.

• 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.

• 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

Cohort 1: Benralizumab-Exposed

• 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

• 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

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 130 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of California, San Diego

OTHER

Sponsor Role: collaborator

AstraZeneca

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christina Chambers, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of California, San Diego

Locations

Research Site

San Diego, California, United States

Countries

United States

Related Links

https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D3250R00026&attachmentIdentifier=6ba559a5-7035-4629-90f4-a5ebcc42d2ed&fileName=OTIS_Benralizumab_Final_Analysis_Report_Synopsis_Redacted.pdf&versionIdentifier=

Redacted CSR synopsis

Other Identifiers

EUPAS26461

Identifier Type: REGISTRY

Identifier Source: secondary_id

D3250R00026

Identifier Type: -

Identifier Source: org_study_id