Clinical trial NCT02957604: Evolocumab Pregnancy Exposure Registry
Official title: Evolocumab Pregnancy Exposure Registry: An OTIS Pregnancy Surveillance Study
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Hypercholesterolemia; ASCVD; Pregnancy
Keywords: Pregnancy; Cardiovascular Diseases; High serum cholesterol; FH; ASCVD
Lead sponsor: Amgen
Sponsor class: INDUSTRY
Collaborators: name: Organization of Teratology Information Specialists (OTIS) Research Center - tel: 1-866-626-6847 or www.mothertobaby.org
First posted: 2016-11-08
Enrollment: 140
Sex: FEMALE
Minimum age (years): 1
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women diagnosed with ASCVD or hypercholesterolemia associated with FH and pregnant women who have been exposed to Evolocumab (Repatha) during pregnancy and who reside in the U.S. or Canada

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

Detailed description: 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.

Eligibility 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

Primary outcomes:
measure: Rate of major structural defects
timeFrame: Up to 1 year of age
Secondary outcomes:
measure: Pregnancy Outcome: Rate of spontaneous abortion
timeFrame: Up to 19 wks post LMP
measure: Pregnancy Outcome: Rate of elective abortion
timeFrame: Through 9 month pregnancy period
measure: Pregnancy Outcome: Rate of stillbirth
timeFrame: At or after 19 completed weeks post LMP
measure: Pregnancy Outcome: Rate of premature delivery
timeFrame: Prior to 37 weeks of gestation
measure: Infant Outcome: Rate of minor structural defects
timeFrame: Between birth and 12 months post natal
measure: Infant Outcome: Rate of small for gestational age
timeFrame: At birth
measure: Infant Outcome: Rate of postnatal growth deficiency
timeFrame: Up to 1 year of age
measure: Infant Outcome: Rate of postnatal hospitalizations
timeFrame: Through 5 years postnatal
measure: Infant Outcome: Rate of infant reactions to scheduled vaccinations
timeFrame: Through 5 years postnatal
measure: Infant Outcome: Infant response to IgG-tetanus antibody
timeFrame: Between 6-12 months of age
measure: Infant Outcome: Adverse neurodevelopment outcomes
timeFrame: Between 16 months to 17 months 30 days of age and between 3.5-5 years of age
measure: Breastfeeding/Lactation Outcome: Proportion of women who breastfed
timeFrame: Through 6 weeks post delivery
measure: Breastfeeding/Lactation Outcome: Proportion who breastfed exclusively
timeFrame: Through the first 2 weeks postnatal
measure: Infant Outcome: Pattern of minor structural defects
timeFrame: Between birth and 12 months postnatal
measure: Infant Outcome: Rate of postnatal serious infections
timeFrame: Through 5 years postnatal
Other outcomes:
Locations:
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References: