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

November 19, 2020 updated by: Regeneron Pharmaceuticals

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.

Study Overview

Status

Terminated

Study Type

Observational

Enrollment (Actual)

37

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • California
      • San Diego, California, United States, 00000
        • Investigational site UNITED STATES

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Pregnant women who enroll in the study will participate for the duration of that pregnancy.Those who deliver at least one live born infant and the infants will participate for 5 years after delivery of that infant.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Pharmaceutical form:as per routine practice Route of administration: subcutaneous
Other Names:
  • Praluent®
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of major structural birth defects
Time Frame: Up to 1 year of age of the infant
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)
Up to 1 year of age of the infant

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pregnancy outcome: Spontaneous abortion
Time Frame: Date of conception to 20 weeks gestation
Rate of spontaneous abortion
Date of conception to 20 weeks gestation
Pregnancy outcome: Elective abortion
Time Frame: Date of conception to 20 weeks gestation
Rate of elective abortion
Date of conception to 20 weeks gestation
Pregnancy outcome: Still birth
Time Frame: At birth
Rate of still birth
At birth
Pregnancy outcome: Preterm delivery
Time Frame: Live birth prior to 37 weeks gestation
Rate of preterm delivery
Live birth prior to 37 weeks gestation
Infant outcome: Pattern of minor structural birth defects
Time Frame: Up to 1 year of age of the infant
Specific pattern of 3 or more minor structural defects in live born infants receiving the exam
Up to 1 year of age of the infant
Infant outcome: Small for gestational age
Time Frame: At birth
Proportion of infants who are small for gestational age on weight, length, or head circumference
At birth
Infant outcome: Postnatal growth deficiency
Time Frame: Up to 1 year of age of the infant
Proportion of infants less than or equal to the 10th percentile for sex and age on weight, length, or head circumference at 1 year postnatal evaluation
Up to 1 year of age of the infant
Infant outcome: serious infections or hospitalizations, adverse reactions to childhood vaccinations
Time Frame: Up to 5 years of age of the child
Proportion of infants who experienced serious infections or hospitalizations, and adverse reactions to childhood vaccinations
Up to 5 years of age of the child
Infant outcome: adequacy of immune response
Time Frame: Up to 5 years of age of the child
Proportion of infants who has adequate immune response as measured by IgG-Tetanus antibody
Up to 5 years of age of the child
Infant outcome: adverse neurodevelopment
Time Frame: Up to 5 years of age of the child
Proportion of infants who experienced adverse neurodevelopment
Up to 5 years of age of the child
Breastfeeding/Lactation outcome
Time Frame: Up to 6 weeks of age of the infant
Proportion of patients breastfeeding in the first 6 weeks after delivery
Up to 6 weeks of age of the infant
Breastfeeding/Lactation outcome
Time Frame: Up to 2 years of age of the child
Proportion of patients breastfeeding exclusively for more than 2 weeks
Up to 2 years of age of the child
Adverse events
Time Frame: Up to 5 years follow-up period
Proportion of patients who experienced adverse events (AEs), AEs of special interest, and serious AEs
Up to 5 years follow-up period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 19, 2017

Primary Completion (ACTUAL)

September 4, 2020

Study Completion (ACTUAL)

September 4, 2020

Study Registration Dates

First Submitted

December 15, 2017

First Submitted That Met QC Criteria

December 18, 2017

First Posted (ACTUAL)

December 20, 2017

Study Record Updates

Last Update Posted (ACTUAL)

November 23, 2020

Last Update Submitted That Met QC Criteria

November 19, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • OBS14703
  • U1111-1195-6468 (OTHER: UTN)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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