Status:
TERMINATED
Praluent® (Alirocumab) Pregnancy Exposure Registry: An OTIS Pregnancy Surveillance Study
Lead Sponsor:
Regeneron Pharmaceuticals
Collaborating Sponsors:
Sanofi
Conditions:
Hypercholesterolemia
Eligibility:
FEMALE
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 hypercholesterolem...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
December 19 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 4 2020
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT03379558
Start Date
December 19 2017
End Date
September 4 2020
Last Update
November 23 2020
Active Locations (1)
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1
Investigational site UNITED STATES
San Diego, California, United States, 00000