Evolocumab Pregnancy Exposure Registry

Amgen140 enrolled

Overview

This is a prospective observational registry study to evaluate fetal, infant and childhood outcomes in women exposed to evolocumab during pregnancy

This pregnancy registry will be conducted by University of California Research Center for the Organization of Teratology Information Specialists (OTIS) which is a network of university and health department based telephone information centers serving pregnant women and healthcare providers throughout North America. Participants will be enrolled on an ongoing basis through year 10 of the study and each will be followed from the time they enroll, through the 5-year postnatal follow up period for an overall study period of 15 years. Participants are recruited concurrently from callers to OTIS centers, from healthcare providers and through direct to consumer marketing efforts.

Study Type

OBSERVATIONAL

Enrollment

140

Conditions

Hypercholesterolemia; ASCVD; Pregnancy

Interventions

evolocumabDRUG

Pregnant women exposed to evolocumab. Evolocumab is not administered in this non-interventional study.

Eligibility

Sex: FEMALEMin age: 1 YearMax age: 100 Years

Medical Language ↔ Plain English

Inclusion Criteria: * For all groups: Qualified subjects will agree to the conditions and requirements of the study including the interview schedule, release of medical records, the physical examination of live born infants, and 5 years of follow-up. * For the Specific Evolocumab-Exposed Cohort: Currently pregnant women (maternal report validated by medical records) diagnosed with ASCVD, or hypercholesterolemia associated with FH who have been exposed to evolocumab for any number of days, at any dose, and at any time from the first day of the LMP up to and including the end of pregnancy. * For Comparison Group I: Currently pregnant women (maternal report validated by medical records) diagnosed with ASCVD, or hypercholesterolemia associated with FH but who were not exposed to evolocumab during pregnancy or any time within 90 days prior to the first day of the LMP. * For Comparison Group II: Currently pregnant women not diagnosed with ASCVD, or hypercholesterolemia associated with FH who have not been exposed to evolocumab during pregnancy or any time within 90 days prior to the first day of the LMP, and who have no exposure to any known human teratogens as determined by the OTIS Research Center * For General Evolocumab-Exposed Case Series group: Women with exposure to evolocumab during pregnancy who do not meet the criteria for the Specific Evolocumab-Exposed cohort for reasons including (but not limited to): they do not have ASCVD and/or hypercholesterolemia associated with FH (off-label use), they were exposed to evolocumab but the pregnancy has already completed, they enrolled in the cohort study with a previous pregnancy, or they already have a prenatal diagnosis of a major birth defect Exclusion Criteria: For all groups except the General Evolocumab Exposed Case Series Group: * Women who first contact the Registry after prenatal diagnosis of a major structural defect * Women who were exposed to a different PCSK9 inhibitor during their current pregnancy or at any time within 5 half-lives prior to the first day of the LMP * Women who have enrolled in this Registry with a previous pregnancy

Outcomes

Primary Outcomes

Rate of major structural defects

Rate of major structural defects, defined and classified by the Centers for Disease Control and Prevention (CDC) Metropolitan Atlanta Congenital Defects Program (MACDP) 6 Digit Code Defects List coding manual (CDC, 2007)

Time frame: Up to 1 year of age

Secondary Outcomes

Pregnancy Outcome: Rate of spontaneous abortion

Rate of spontaneous abortion where spontaneous abortion is defined as non-deliberate fetal death which occurs prior to 19 completed weeks post-last menstrual period (LMP)

Time frame: Up to 19 wks post LMP

Pregnancy Outcome: Rate of elective abortion

Rate of elective abortion where elective abortion is defined as deliberate termination of pregnancy at any time in gestation

Time frame: Through 9 month pregnancy period

Pregnancy Outcome: Rate of stillbirth

Rate of stillbirth where stillbirth is defined as non-deliberate fetal death anytime in gestation at or after 19 completed weeks post-LMP

Time frame: At or after 19 completed weeks post LMP

Pregnancy Outcome: Rate of premature delivery

Rate of premature delivery where premature delivery is defined as live birth prior to 37.0 weeks gestation as counted from LMP (or ultrasound adjusted date)

Time frame: Prior to 37 weeks of gestation

Infant Outcome: Rate of minor structural defects

Rate of minor structural defects where a minor structural defect is defined as a structural anomaly which has neither cosmetic nor functional significance to the child.

Time frame: Between birth and 12 months post natal

Data from ClinicalTrials.gov

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