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

Regeneron Pharmaceuticals

Status: Terminated

Conditions: Hypercholesterolemia

Treatments: Drug: ALIROCUMAB SAR236553 (REGN727)

Study type: Observational

Funder types: Industry

Identifiers

NCT03379558

OBS14703

U1111-1195-6468 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 37 patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

Cohort 1: Alirocumab-Exposed:

Currently pregnant - Diagnosed with primary hypercholesterolemia and atherosclerotic cardiovascular disease, or primary hypercholesterolemia associated with familial hypercholesterolemia - Exposed to alirocumab for any number of days, at any dose, and at any time from the first day of the last menstrual period up to and including the end of pregnancy - Agree to the conditions and requirements of the study and provide informed consent.

Cohort 2: Disease-Matched Comparison:

Currently pregnant - Diagnosed with primary hypercholesterolemia and atherosclerotic cardiovascular disease, or primary hypercholesterolemia associated with familial hypercholesterolemia - Unexposed to alirocumab or any biologic medication during pregnancy or any time within 10 weeks prior to the first day of the last menstrual period - Agree to the conditions and requirements of the study and provide informed consent.

Cohort 3: Non-Diseased Comparison:

Currently pregnant - Not diagnosed with primary hypercholesterolemia and atherosclerotic cardiovascular disease, or primary hypercholesterolemia associated with familial hypercholesterolemia - Unexposed to alirocumab or any biologic any time in pregnancy or within 10 weeks prior to the first day of the last menstrual period - Unexposed to any known human teratogens as determined by the Organization of Teratology Information Specialists Research Center - Agree to the conditions and requirements of the study and provide informed consent.

Exclusion criteria

Cohort 1: Alirocumab-Exposed:

First contact the Registry after prenatal diagnosis of a major structural birth defect - Enrollment in this pregnancy registry study with a previous pregnancy - Pregnancy outcome is reported retrospectively.

Cohort 2: Disease-Matched Comparison:

First contact the Registry after prenatal diagnosis of a major structural birth defect - Exposure to any alirocumab or other biologic medication during pregnancy or within 10 weeks prior to the first day of the last menstrual period - Enrollment in this pregnancy registry study with a previous pregnancy - Pregnancy outcome is reported retrospectively.

Cohort 3: Non-Diseased Comparison:

First contact the Registry after prenatal diagnosis of a major structural birth defect - Exposure to alirocumab or other biologic medication during pregnancy or within 10 weeks prior to the first day of the last menstrual period - Exposure to a known human teratogen as determined by the Organization of Teratology Information Specialists Research Center - Enrollment in this pregnancy registry study with a previous pregnancy - Pregnancy outcome is reported retrospectively.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Trial design

37 participants in 3 patient groups

Cohort 1 : alirocumab exposed

Description:

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.

Treatment:

Drug: ALIROCUMAB SAR236553 (REGN727)

Cohort 2 : disease matched comparison

Description:

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.

Cohort 3 : non disease comparison

Description:

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.