Benralizumab Pregnancy Exposure Study
Key facts
- Who runs it
- AstraZeneca
- Where
- San Diego, United StatesSee the site
- Trial code
- Status
- Terminated
- People taking part
- 299 people enrolled
- Started
- 20 Mar 2019
- Ended
- 29 Dec 2023
- Type of study
- Observational, 3 groups
- Treatments tested
- Benralizumab-exposure
- Exposure to other asthma medications
- Record updated
- 22 November 2024
- Why it stopped
- The decision to terminate the Fasenra pregnancy study and cancel the commitment to conduct additional pregnancy-related pharmacovigilance activities was made by the EMA following MAH's failed attempts to address patient recruitment challenges.
Who can take part
- Age
- 18 years to 130 years
- Sex
- Women only
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 22 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
- 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 with a self-reported diagnosis of asthma, current or previous
- Retrospective cases (outcome of pregnancy known prior to enrollment)
- Women who have enrolled in the current study with a previous pregnancy
- 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
- 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
- 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 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
Other criteria
- Participants will be recruited into the three cohorts concurrently, on the basis of the following inclusion/exclusion criteria:
- Cohort 1: Benralizumab-Exposed
Where in United States
- San Diego, CaliforniaHospital not named in the registry
About the trial
What the trial wants to find out
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)
Read full original descriptionShow less
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).
The 3 groups in the trial
- Benralizumab-exposed group
Pregnant women with asthma exposed to benralizumab anytime during pregnancy or within 8 weeks prior to last menstrual period
Treatment: 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
Treatment: 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.
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- The Benralizumab Pregnancy Exposure Study: A VAMPSS Post Marketing Surveillance Study
- Record updated
- 22 November 2024