AsthmaNCT03794999
Benralizumab Pregnancy Exposure Study
An observational study of Asthma, run by AstraZeneca at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 130 years, women only
- Conditions the study is for
- Asthma
- What is being tested?
- Benralizumab-exposure and Exposure to other asthma medications
- How many people
- 299 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Mar 2019to 29 Dec 2023
- How long will I take part?
- 20 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 130 years
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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 join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Benralizumab Pregnancy Exposure Study: A VAMPSS Post Marketing Surveillance Study
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
- Being tested
- Benralizumab-exposure, Exposure to other asthma medications
- Keywords
- asthma, pregnancy, benralizumab, infant, teratogenic
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Benralizumab-exposureDrug
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).
Exposure to other asthma medicationsDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Benralizumab-exposed group | Pregnant women with asthma exposed to benralizumab anytime during pregnancy or within 8 weeks prior to last menstrual period Receives: 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 Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to 1 year of age
Secondary outcomes (6)
Spontaneous abortion/miscarriage
Spontaneous pregnancy loss prior to 20.0 weeks gestation, since women only enrol after recognition of pregnancy, spontaneous abortions are only identified after enrolment in clinically recognised pregnancies.
Measured: Prior to 20.0 weeks gestation
Preterm delivery
Pregnancies enrolled prior to 37.0 weeks' gestation and ending in at least one live born infant. Excludes twins or higher order multiples due to inherent higher risk of preterm birth in multiples. Exposure can occur any time in pregnancy prior to the event.
Measured: Prior to 37 weeks of gestation
Small for gestational age infants
Pregnancies ending in at least one live born infant who are <10th centile on birth weight, length and/or head circumference for infant sex and gestational age; excluding twins or higher order multiples due to the inherent higher risk of reduced birth size in multiples. Exposure can occur any time in pregnancy prior to the event.
Measured: At birth
Stillbirth
Stillbirth is defined as a fetal death that occurs >20 weeks' gestation. All pregnancies, excluding lost-to-follow-up. Exposure can occur any time in pregnancy prior to the event.
Measured: At delivery
Elective termination/abortion
Elective termination is defined as deliberate interruption of pregnancy by surgical or medical means. All pregnancies, excluding lost-to-follow-up. Exposure can occur anytime in pregnancy prior to the event.
Measured: At the end of pregnancy, or through 9 month pregnancy period
Small for age postnatal growth of live born children to 1 year of age
Postnatal growth is measured at approximately 1 year of age among live born infants and age and sex specific percentiles assigned using standard U.S. growth curves. Weight, length and/or head circumference <10th centile will be considered small for age. Multiples are excluded. Exposure can occur anytime in pregnancy.
Measured: Up to one year of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2019
- Study start20 Mar 2019
- Primary completion29 Dec 2023
- Study completion29 Dec 2023
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.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 299 participants (actual)
- Target duration
- 20 Months
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of California, San Diego
- Responsible party
- Sponsor
- Investigators
- Christina Chambers, PhD, MPH, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03794999
- Sponsor's protocol ID
- D3250R00026
- Other IDs
- EUPAS26461
- Status last verified
- Nov 2024
- First submitted
- 4 Dec 2018
- Last updated
- 22 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Benralizumab Pregnancy Exposure Study: A VAMPSS Post Marketing Surveillance Study
- ClinicalTrials.gov ID
- NCT03794999
- Acronym / sponsor ID
- D3250R00026
- Conditions
- Asthma
- Keywords
- asthma, pregnancy, benralizumab, infant, teratogenic
- Study type
- Observational
- Recruitment status
- TerminatedReason 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.
- Enrolment
- 299 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- University of California, San Diego
- Study start
- 20 Mar 2019 (actual)
- Primary completion
- 29 Dec 2023 (actual)
- Study completion
- 29 Dec 2023 (actual)
- First posted
- 7 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 20 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Benralizumab-exposed group | – | Drug: Benralizumab-exposurePregnant women with asthma exposed to benralizumab anytime during pregnancy or within 8 weeks prior to last menstrual period |
| Asthmatic comparison group | – | Drug: Exposure to other asthma medicationsPregnant women currently treated for asthma not exposed to benralizumab during pregnancy or within 8 weeks prior to last menstrual period |
| 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. |
Who may qualify
- Ages
- 18 to 130 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Benralizumab-exposureExposure 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). | Drug | Benralizumab-exposed group |
| Exposure to other asthma medicationsExposure 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. | Drug | Asthmatic comparison group |
Primary outcome
Major structural birth defects
Time frame: Up to 1 year of age
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
6 secondary outcomes
Spontaneous abortion/miscarriage
Time frame: Prior to 20.0 weeks gestation
Preterm delivery
Time frame: Prior to 37 weeks of gestation
Small for gestational age infants
Time frame: At birth
Stillbirth
Time frame: At delivery
Elective termination/abortion
Time frame: At the end of pregnancy, or through 9 month pregnancy period
Small for age postnatal growth of live born children to 1 year of age
Time frame: Up to one year of age
Results and safety
The study was stopped early (reason given: 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.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2024.
- Redacted CSR synopsisLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christina Chambers, PhD, MPH principal investigator
University of California, San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma, run by AstraZeneca at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: 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.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major structural birth defects (time frame: Up to 1 year of age). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2024; AzTrials last refreshed its copy on 30 Oct 2026.