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Praluent® (Alirocumab) Pregnancy Exposure Registry: An OTIS Pregnancy Surveillance Study

NCT03379558 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 37

Last updated 2020-11-23

No results posted yet for this 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.

Conditions

Interventions

DRUG

ALIROCUMAB SAR236553 (REGN727)

Pharmaceutical form:as per routine practice Route of administration: subcutaneous

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Eligibility

Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-12-19
Primary Completion
2020-09-04
Completion
2020-09-04
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03379558 on ClinicalTrials.gov