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NCT03379558 · ClinicalTrials.gov registry record
Praluent® (Alirocumab) Pregnancy Exposure Registry: An OTIS Pregnancy Surveillance Study
A clinical trial, sponsored by Regeneron Pharmaceuticals.
- Terminated
- Registry status
- 37
- Enrollment target
NCT03379558: Clinical Trial study, sponsored by Regeneron Pharmaceuticals.
NCT03379558 is a clinical trial that was terminated before completion, run by Regeneron Pharmaceuticals. The registered enrollment target is 37 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03379558 was terminated before completion, sponsored by Regeneron Pharmaceuticals.
- TERMINATED
- Registry status
- 37 participants
- Enrollment target
Study Summary
Primary Objective: To estimate the overall combined rate of major structural birth defects in infants of mothers with atherosclerotic cardiovascular disease (ASCVD) and/or familial hypercholesterolemia (FH) exposed to Praluent® (alirocumab) during pregnancy when used to treat hypercholesterolemia and to compare that rate to unexposed disease-matched and unexposed non-diseased comparison pregnancies. Secondary Objectives: * Secondary objectives are to estimate the rates of the outcomes in pregnancies/infants of mothers with atherosclerotic cardiovascular disease and/or familial hypercholesterolemia exposed to alirocumab during pregnancy when used to treat hypercholesterolemia and to compare that rate to unexposed disease-matched and non-diseased comparison pregnancies, and secondarily to compare the rates of these outcomes in the unexposed disease-matched pregnancies to the rates in the unexposed non-diseased comparison pregnancies. * Safety and tolerability of alirocumab.
Primary Outcome
Overall combined rate of major structural birth defects in infants born to females with atherosclerotic cardiovascular disease (ASCVD) and/or familial hypercholesterolemia (FH) exposed to Praluent (alirocumab)
Interventions
- DRUG ALIROCUMAB SAR236553 (REGN727)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 37 participants |
| Start Date | 2017-12-19 |
| Est. Completion | 2020-09-04 |
Why NCT03379558 stopped before completion
NCT03379558 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 37 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which ALIROCUMAB SAR236553 (REGN727) is the first listed.
NCT03379558 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03379558 about?
NCT03379558 is a clinical study titled "Praluent® (Alirocumab) Pregnancy Exposure Registry: An OTIS Pregnancy Surveillance Study". Primary Objective: To estimate the overall combined rate of major structural birth defects in infants of mothers with atherosclerotic cardiovascular disease (ASCVD) and/or familial hypercholesterolemia (FH) exposed to Praluent® (alirocumab) during pregnancy when used to treat hypercholesterolemia a...
What is the current status of trial NCT03379558?
This trial is currently terminated. The enrollment target is 37 participants. The study started on 2017-12-19. Estimated completion is 2020-09-04.
What interventions are being tested in trial NCT03379558?
The interventions under investigation include: ALIROCUMAB SAR236553 (REGN727) (DRUG).
Who is sponsoring clinical trial NCT03379558?
This trial is sponsored by Regeneron Pharmaceuticals, which has 280 total clinical trials registered on ClinicalTrials.gov.
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