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

Hypercholesterolemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03379558
• Other study ID #: OBS14703
• Secondary ID: U1111-1195-6468
• Status: Terminated
• Start date: December 19, 2017
• Est. completion date: September 4, 2020

Study information

• Verified date: November 2020
• Source: Regeneron Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 37
• Est. completion date: September 4, 2020
• Est. primary completion date: September 4, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Hypercholesterolemia

Intervention

Drug:
• ALIROCUMAB SAR236553 (REGN727)
Pharmaceutical form:as per routine practice Route of administration: subcutaneous

Locations

Country	Name	City	State
United States	Investigational site UNITED STATES	San Diego	California

Sponsors (2)

Lead Sponsor	Collaborator
Regeneron Pharmaceuticals	Sanofi

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of major structural birth defects	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)	Up to 1 year of age of the infant
Secondary	Pregnancy outcome: Spontaneous abortion	Rate of spontaneous abortion	Date of conception to 20 weeks gestation
Secondary	Pregnancy outcome: Elective abortion	Rate of elective abortion	Date of conception to 20 weeks gestation
Secondary	Pregnancy outcome: Still birth	Rate of still birth	At birth
Secondary	Pregnancy outcome: Preterm delivery	Rate of preterm delivery	Live birth prior to 37 weeks gestation
Secondary	Infant outcome: Pattern of minor structural birth defects	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
Secondary	Infant outcome: Small for gestational age	Proportion of infants who are small for gestational age on weight, length, or head circumference	At birth
Secondary	Infant outcome: Postnatal growth deficiency	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	Up to 1 year of age of the infant
Secondary	Infant outcome: serious infections or hospitalizations, adverse reactions to childhood vaccinations	Proportion of infants who experienced serious infections or hospitalizations, and adverse reactions to childhood vaccinations	Up to 5 years of age of the child
Secondary	Infant outcome: adequacy of immune response	Proportion of infants who has adequate immune response as measured by IgG-Tetanus antibody	Up to 5 years of age of the child
Secondary	Infant outcome: adverse neurodevelopment	Proportion of infants who experienced adverse neurodevelopment	Up to 5 years of age of the child
Secondary	Breastfeeding/Lactation outcome	Proportion of patients breastfeeding in the first 6 weeks after delivery	Up to 6 weeks of age of the infant
Secondary	Breastfeeding/Lactation outcome	Proportion of patients breastfeeding exclusively for more than 2 weeks	Up to 2 years of age of the child
Secondary	Adverse events	Proportion of patients who experienced adverse events (AEs), AEs of special interest, and serious AEs	Up to 5 years follow-up period