Evolocumab Pregnancy Exposure Registry

Conditions

• Hypercholesterolemia; ASCVD; Pregnancy

Eligibility Criteria

Sex

FEMALE

Age

1 Year - 100 Years

Healthy Volunteers

Not accepted

Interventions

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

Study Details

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

Key Dates

Start date

Dec 22, 2016

Status verified

Dec 2020

Primary completion

Sep 2, 2020

Completion

Sep 2, 2020

Study Design

Enrollment

140 participants (actual)

Arms

• Arm: Specific Evolocumab-Exposed Cohort
  Women diagnosed with Atherosclerotic Cardiovascular Disease (ASCVD), or hypercholesterolemia associated with Familial Hypercholesterolemia (FH), who were exposed to Evolocumab (Repatha) during pregnancy
• Arm: Comparison Group I
  Women diagnosed with Atherosclerotic Cardiovascular Disease (ASCVD), or hypercholesterolemia associated with Familial Hypercholesterolemia (FH) who were not exposed to Evolocumab during pregnancy
• Arm: Comparison Group II
  A general comparison group of pregnant women who have not been diagnosed with Atherosclerotic Cardiovascular Disease (ASCVD), or hypercholesterolemia associated with Familial Hypercholesterolemia (FH), and who were not exposed to Evolocumab during pregnancy.
• Arm: General Evolocumab-Exposed Case Series
  Women who were exposed to Evolocumab (Repatha) but do not fulfill eligibility criteria for the Specific Evolocumab-Exposed Cohort

Primary Outcome Measure

Rate of major structural defects [ Time Frame: Up to 1 year of age ]