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

Part of paid clinical trials in San Diego, California.

Sponsor
Regeneron Pharmaceuticals
Study ID
NCT03379558
Status
Terminated

Conditions

Eligibility Criteria

Sex
FEMALE
Age
N/A - N/A
Healthy Volunteers
Accepted

Interventions

Study Details

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.

Key Dates

Start date
Dec 19, 2017
Status verified
Nov 2020
Primary completion
Sep 4, 2020
Completion
Sep 4, 2020

Study Design

Enrollment
37 participants (actual)

Arms

  • Arm: Cohort 1 : alirocumab exposed
    Pregnant women diagnosed with primary hypercholesterolemia and atherosclerotic cardiovascular disease, or primary hypercholesterolemia associated with familial hypercholesterolemia and exposed to alirocumab during the current pregnancy.
  • Arm: Cohort 2 : disease matched comparison
    Pregnant women diagnosed of primary hypercholesterolemia and atherosclerotic cardiovascular disease, or primary hypercholesterolemia associated with familial hypercholesterolemia and unexposed to alirocumab during the current pregnancy.
  • Arm: Cohort 3 : non disease comparison
    Healthy pregnant women who do not have a known diagnosis of primary hypercholesterolemia and atherosclerotic cardiovascular disease, or primary hypercholesterolemia associated with familial hypercholesterolemia and have no known exposure to a known human teratogen.

Primary Outcome Measure

Rate of major structural birth defects [ Time Frame: Up to 1 year of age of the infant ]

Locations (1)

FacilityCityStateZIPSite coordinators
Investigational site UNITED STATESSan DiegoCalifornia00000-

Find similar trials in San Diego, CA

By research site
Investigational site UNITED STATES· San Diego, CA

Related Studies