- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03379558
Praluent® (Alirocumab) Pregnancy Exposure Registry: An OTIS Pregnancy Surveillance Study
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
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
California
-
San Diego, California, United States, 00000
- Investigational site UNITED STATES
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
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:
|
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.
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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)
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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
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Pregnancy outcome: Elective abortion
Time Frame: Date of conception to 20 weeks gestation
|
Rate of elective abortion
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Date of conception to 20 weeks gestation
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Pregnancy outcome: Still birth
Time Frame: At birth
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Rate of still birth
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At birth
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Pregnancy outcome: Preterm delivery
Time Frame: Live birth prior to 37 weeks gestation
|
Rate of preterm delivery
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Live birth prior to 37 weeks gestation
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Infant outcome: Pattern of minor structural birth defects
Time Frame: Up to 1 year of age of the infant
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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
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Proportion of infants who are small for gestational age on weight, length, or head circumference
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At birth
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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
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Up to 1 year of age of the infant
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Infant outcome: serious infections or hospitalizations, adverse reactions to childhood vaccinations
Time Frame: Up to 5 years of age of the child
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Proportion of infants who experienced serious infections or hospitalizations, and adverse reactions to childhood vaccinations
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Up to 5 years of age of the child
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Infant outcome: adequacy of immune response
Time Frame: Up to 5 years of age of the child
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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
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Breastfeeding/Lactation outcome
Time Frame: Up to 2 years of age of the child
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Proportion of patients breastfeeding exclusively for more than 2 weeks
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Up to 2 years of age of the child
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Adverse events
Time Frame: Up to 5 years follow-up period
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Proportion of patients who experienced adverse events (AEs), AEs of special interest, and serious AEs
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Up to 5 years follow-up period
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Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- OBS14703
- U1111-1195-6468 (OTHER: UTN)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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