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NCT03794999 · ClinicalTrials.gov registry record
Benralizumab Pregnancy Exposure Study
A clinical trial, sponsored by AstraZeneca.
- Terminated
- Registry status
- 299
- Enrollment target
NCT03794999: Clinical Trial study, sponsored by AstraZeneca.
NCT03794999 is a clinical trial that was terminated before completion, run by AstraZeneca. The registered enrollment target is 299 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03794999 was terminated before completion, sponsored by AstraZeneca.
- TERMINATED
- Registry status
- 299 participants
- Enrollment target
Study 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).
Primary Outcome
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
Interventions
- DRUG Benralizumab-exposure
- DRUG Exposure to other asthma medications
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 299 participants |
| Start Date | 2019-03-20 |
| Est. Completion | 2023-12-29 |
Why NCT03794999 stopped before completion
NCT03794999 is an observational study that tracks outcomes without assigning an intervention. The registered 299 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 2 interventions - of which Benralizumab-exposure is the first listed.
NCT03794999 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03794999 about?
NCT03794999 is a clinical study titled "Benralizumab Pregnancy Exposure 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 unplann...
What is the current status of trial NCT03794999?
This trial is currently terminated. The enrollment target is 299 participants. The study started on 2019-03-20. Estimated completion is 2023-12-29.
What interventions are being tested in trial NCT03794999?
The interventions under investigation include: Benralizumab-exposure (DRUG), Exposure to other asthma medications (DRUG).
Who is sponsoring clinical trial NCT03794999?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
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