NCT03379558

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

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 37 (actual)
• Sponsor: Regeneron Pharmaceuticals · Industry
• Sex: Female
• Age: —
• Healthy volunteers: Accepted

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

• Hypercholesterolemia

Interventions

Type	Name	Description
DRUG	ALIROCUMAB SAR236553 (REGN727)	Pharmaceutical form:as per routine practice Route of administration: subcutaneous

Timeline

• Start date: 2017-12-19
• Primary completion: 2020-09-04
• Completion: 2020-09-04
• First posted: 2017-12-20
• Last updated: 2020-11-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study