Praluent® (Alirocumab) Pregnancy Exposure Registry: An OTIS Pregnancy Surveillance Study
| Status: | Recruiting |
|---|---|
| Conditions: | High Cholesterol |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/12/2018 |
| Start Date: | December 19, 2017 |
| End Date: | September 2028 |
| Contact: | Trial Transparency email recommended (Toll free number for US & Canada) |
| Email: | Contact-Us@sanofi.com |
| Phone: | 800-633-1610 |
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.
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.
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.
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