Evolocumab Pregnancy Exposure Registry: An OTIS Pregnancy Surveillance Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Amgen
- 入组人数
- 140
- 主要终点
- Rate of major structural defects
研究概览
简要总结
This is a prospective observational registry study to evaluate fetal, infant and childhood outcomes in women exposed to evolocumab during pregnancy
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Year 至 100 Years（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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
干预措施: evolocumab (Drug)
General Evolocumab-Exposed Case Series
Women who were exposed to Evolocumab (Repatha) but do not fulfill eligibility criteria for the Specific Evolocumab-Exposed Cohort
干预措施: evolocumab (Drug)
结局指标
主要结局
Rate of major structural defects
时间窗: Up to 1 year of age
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)
次要结局
- Pregnancy Outcome: Rate of spontaneous abortion(Up to 19 wks post LMP)
- Infant Outcome: Rate of minor structural defects(Between birth and 12 months post natal)
- Infant Outcome: Rate of postnatal growth deficiency(Up to 1 year of age)
- Infant Outcome: Rate of postnatal hospitalizations(Through 5 years postnatal)
- Pregnancy Outcome: Rate of elective abortion(Through 9 month pregnancy period)
- Pregnancy Outcome: Rate of stillbirth(At or after 19 completed weeks post LMP)
- Infant Outcome: Rate of small for gestational age(At birth)
- Breastfeeding/Lactation Outcome: Proportion of women who breastfed(Through 6 weeks post delivery)
- Breastfeeding/Lactation Outcome: Proportion who breastfed exclusively(Through the first 2 weeks postnatal)
- Infant Outcome: Pattern of minor structural defects(Between birth and 12 months postnatal)
- Pregnancy Outcome: Rate of premature delivery(Prior to 37 weeks of gestation)
- Infant Outcome: Rate of postnatal serious infections(Through 5 years postnatal)
- Infant Outcome: Rate of infant reactions to scheduled vaccinations(Through 5 years postnatal)
- Infant Outcome: Infant response to IgG-tetanus antibody(Between 6-12 months of age)
- Infant Outcome: Adverse neurodevelopment outcomes(Between 16 months to 17 months 30 days of age and between 3.5-5 years of age)