Benralizumab Pregnancy Exposure Study

NCT03794999 | Terminated DMC

• 2 other identifiers: D3250R00026EUPAS26461
• Study Type: observational
• Target: 299
• Locations: 1 country
• Sites: 1

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

Keywords

asthma; pregnancy; benralizumab; infant; teratogenic

Outcome Measures

Primary Outcomes (1)

• Major structural birth defects

  Pregnancies ending in live birth with exposure in the first trimester for benralizumab cohort, and other comparison groups at least one malformed infant in an individual pregnancy is considered one malformed outcome

  Up to 1 year of age

Secondary Outcomes (6)

• Spontaneous abortion/miscarriage

  Prior to 20.0 weeks gestation

• Preterm delivery

  Prior to 37 weeks of gestation

• Small for gestational age infants

  At birth

• Stillbirth

  At delivery

• Elective termination/abortion

  At the end of pregnancy, or through 9 month pregnancy period

Study Arms (3)

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

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

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.

Interventions

Benralizumab-exposure 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).

Benralizumab-exposed group

Exposure to other asthma medications 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.

Asthmatic comparison group

Eligibility Criteria

• Age: 18 Years - 130 Years
• Gender Eligibility Details: Pregnant women who have or have not used benralizumab anytime in pregnancy for asthma.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population includes pregnant women who reside in the US or Canada who have or have not used benralizumab anytime in pregnancy for asthma.

You may not qualify if:

• 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.
• 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
• 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.
• 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

Sponsors & Collaborators

• AstraZeneca: lead
• University of California, San Diego: collaborator

Study Sites (1)

Research Site

San Diego, California, 92103, United States

Location

Related Links

• Redacted CSR synopsis

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Christina Chambers, PhD, MPH

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 20 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2018
• First Posted: January 7, 2019
• Study Start: March 20, 2019
• Primary Completion: December 29, 2023
• Study Completion: December 29, 2023
• Last Updated: November 22, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)