Praluent® (Alirocumab) Pregnancy Exposure Registry: An OTIS Pregnancy Surveillance Study
- Registration Number
- NCT03379558
- Lead Sponsor
- Regeneron Pharmaceuticals
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 37
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Cohort 1 : alirocumab exposed ALIROCUMAB SAR236553 (REGN727) 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.
- Primary Outcome Measures
Name Time Method Rate of major structural birth defects 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)
- Secondary Outcome Measures
Name Time Method Infant outcome: serious infections or hospitalizations, adverse reactions to childhood vaccinations Up to 5 years of age of the child Proportion of infants who experienced serious infections or hospitalizations, and adverse reactions to childhood vaccinations
Infant outcome: adequacy of immune response Up to 5 years of age of the child Proportion of infants who has adequate immune response as measured by IgG-Tetanus antibody
Adverse events Up to 5 years follow-up period Proportion of patients who experienced adverse events (AEs), AEs of special interest, and serious AEs
Infant outcome: adverse neurodevelopment Up to 5 years of age of the child Proportion of infants who experienced adverse neurodevelopment
Breastfeeding/Lactation outcome Up to 2 years of age of the child Proportion of patients breastfeeding exclusively for more than 2 weeks
Pregnancy outcome: Spontaneous abortion Date of conception to 20 weeks gestation Rate of spontaneous abortion
Pregnancy outcome: Elective abortion Date of conception to 20 weeks gestation Rate of elective abortion
Pregnancy outcome: Still birth At birth Rate of still birth
Pregnancy outcome: Preterm delivery Live birth prior to 37 weeks gestation Rate of preterm delivery
Infant outcome: Pattern of minor structural birth defects 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
Infant outcome: Small for gestational age At birth Proportion of infants who are small for gestational age on weight, length, or head circumference
Infant outcome: Postnatal growth deficiency 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
Trial Locations
- Locations (1)
Investigational site UNITED STATES
🇺🇸San Diego, California, United States