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Praluent® (Alirocumab) Pregnancy Exposure Registry: An OTIS Pregnancy Surveillance Study

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ClinicalTrials.gov Identifier: NCT03379558
Recruitment Status : Recruiting
First Posted : December 20, 2017
Last Update Posted : January 10, 2018
Sponsor:
Collaborator:
Regneron Pharmaceuticals
Information provided by (Responsible Party):
Sanofi

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.

Condition or disease Intervention/treatment
Hypercholesterolemia Drug: ALIROCUMAB SAR236553 (REGN727)

Sanofi has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.  

Study Type : Observational
Estimated Enrollment : 375 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Praluent® (Alirocumab) Pregnancy Exposure Registry: An OTIS Pregnancy Surveillance Study
Actual Study Start Date : December 19, 2017
Estimated Primary Completion Date : September 2028
Estimated Study Completion Date : September 2028

Resource links provided by the National Library of Medicine

Drug Information available for: Alirocumab
U.S. FDA Resources

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.
Drug: ALIROCUMAB SAR236553 (REGN727)
Pharmaceutical form:as per routine practice Route of administration: subcutaneous
Other Name: Praluent®
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.



Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. Pregnancy outcome: Spontaneous abortion [ Time Frame: Date of conception to 20 weeks gestation ]
    Rate of spontaneous abortion

  2. Pregnancy outcome: Elective abortion [ Time Frame: Date of conception to 20 weeks gestation ]
    Rate of elective abortion

  3. Pregnancy outcome: Still birth [ Time Frame: At birth ]
    Rate of still birth

  4. Pregnancy outcome: Preterm delivery [ Time Frame: Live birth prior to 37 weeks gestation ]
    Rate of preterm delivery

  5. Infant outcome: Pattern of minor structural birth defects [ Time Frame: 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

  6. Infant outcome: Small for gestational age [ Time Frame: At birth ]
    Proportion of infants who are small for gestational age on weight, length, or head circumference

  7. 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

  8. Infant outcome: serious infections or hospitalizations, adverse reactions to childhood vaccinations [ Time Frame: Up to 5 years of age of the child ]
    Proportion of infants who experienced serious infections or hospitalizations, and adverse reactions to childhood vaccinations

  9. Infant outcome: adequacy of immune response [ Time Frame: Up to 5 years of age of the child ]
    Proportion of infants who has adequate immune response as measured by IgG-Tetanus antibody

  10. Infant outcome: adverse neurodevelopment [ Time Frame: Up to 5 years of age of the child ]
    Proportion of infants who experienced adverse neurodevelopment

  11. 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

  12. Breastfeeding/Lactation outcome [ Time Frame: Up to 2 years of age of the child ]
    Proportion of patients breastfeeding exclusively for more than 2 weeks

  13. Adverse events [ Time Frame: Up to 5 years follow-up period ]
    Proportion of patients who experienced adverse events (AEs), AEs of special interest, and serious AEs



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Pregnant women who enroll in the study will participate for the duration of that pregnancy.Those who deliver at least one live born infant and the infants will participate for 5 years after delivery of that infant.
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03379558


Contacts
Contact: For site information, send an email with site number to Contact-Us@sanofi.com

Locations
United States, New York
Recruiting
New York, New York, United States, 00000
Sponsors and Collaborators
Sanofi
Regneron Pharmaceuticals
Investigators
Study Director: Clinical Sciences & Operations Sanofi

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT03379558     History of Changes
Other Study ID Numbers: OBS14703
U1111-1195-6468 ( Other Identifier: UTN )
First Posted: December 20, 2017    Key Record Dates
Last Update Posted: January 10, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs