Back to Search Results
Terminated/Withdrawn
Sponsor ID
20150338

Evolocumab Pregnancy Exposure Registry

Sponsor ID
20150338
Clinicaltrials.gov ID
NCT02957604
EUCTIS ID
N/A
EudraCT ID
N/A
Contact Us

Study Details

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

Additional Study Details

Phase
Phase 4
Product
Evolocumab
Type
Observational
Masking
N/A
Enrollment
140
Additional Study Details

Protocol Summary

Primary Outcome Measures

Rate of major structural defects

Timeframe: Up to 1 year of age

Secondary Outcome Measures

Pregnancy Outcome: Rate of spontaneous abortion

Timeframe: Up to 19 wks post LMP

Pregnancy Outcome: Rate of elective abortion

Timeframe: Through 9 month pregnancy period

Pregnancy Outcome: Rate of stillbirth

Timeframe: At or after 19 completed weeks post LMP

Pregnancy Outcome: Rate of premature delivery

Timeframe: Prior to 37 weeks of gestation

Infant Outcome: Rate of minor structural defects

Timeframe: Between birth and 12 months post natal

Infant Outcome: Rate of small for gestational age

Timeframe: At birth

Infant Outcome: Rate of postnatal growth deficiency

Timeframe: Up to 1 year of age

Infant Outcome: Rate of postnatal hospitalizations

Timeframe: Through 5 years postnatal

Infant Outcome: Rate of infant reactions to scheduled vaccinations

Timeframe: Through 5 years postnatal

Infant Outcome: Infant response to IgG-tetanus antibody

Timeframe: Between 6-12 months of age

Infant Outcome: Adverse neurodevelopment outcomes

Timeframe: Between 16 months to 17 months 30 days of age and between 3.5-5 years of age

Breastfeeding/Lactation Outcome: Proportion of women who breastfed

Timeframe: Through 6 weeks post delivery

Breastfeeding/Lactation Outcome: Proportion who breastfed exclusively

Timeframe: Through the first 2 weeks postnatal

Infant Outcome: Pattern of minor structural defects

Timeframe: Between birth and 12 months postnatal

Infant Outcome: Rate of postnatal serious infections

Timeframe: Through 5 years postnatal

Locations

No locations found.
Study Info
Age
1 - 100 Years
Condition
  • Cholesterol
    • Sex
    Assigned Female at Birth
    Trial Dates
    Dec 2016 - Sep 2020
    Inclusion and Exclusion Criteria
    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