Benralizumab Pregnancy Exposure Study
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Asthma, Asthma |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 1/9/2019 |
| Start Date: | January 21, 2019 |
| End Date: | November 30, 2025 |
| Contact: | AstraZeneca Clinical Study Information Center |
| Email: | information.center@astrazeneca.com |
| Phone: | 1-877-240-9479 |
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).
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).
Participants will be recruited into the three cohorts concurrently, on the basis of the
following inclusion/exclusion criteria:
Cohort 1: Benralizumab-Exposed
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.
We found this trial at
1
site
9500 Gilman Dr
La Jolla, California 92093
La Jolla, California 92093
(858) 534-2230
Phone: 858-246-1704
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