Praluent® (Alirocumab) Pregnancy Exposure Registry: An OTIS Pregnancy Surveillance Study
Study Details
Study Description
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:
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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.
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Safety and tolerability of alirocumab.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Study Design
Arms and Interventions
| Arm | 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. |
Drug: ALIROCUMAB SAR236553 (REGN727)
Pharmaceutical form:as per routine practice Route of administration: subcutaneous
Other Names:
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| 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. |
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| 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. |
Outcome Measures
Primary Outcome Measures
- 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
- 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
- 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
- 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 6 weeks of age of the infant]
Proportion of patients breastfeeding in the first 6 weeks after delivery
- Breastfeeding/Lactation outcome [Up to 2 years of age of the child]
Proportion of patients breastfeeding exclusively for more than 2 weeks
- Adverse events [Up to 5 years follow-up period]
Proportion of patients who experienced adverse events (AEs), AEs of special interest, and serious AEs
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Investigational site UNITED STATES | San Diego | California | United States | 00000 |
Sponsors and Collaborators
- Regeneron Pharmaceuticals
- Sanofi
Investigators
- Study Director: Clinical Sciences & Operations, Sanofi
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- OBS14703
- U1111-1195-6468