Praluent® (Alirocumab) Pregnancy Exposure Registry: An OTIS Pregnancy Surveillance Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Rate of major structural birth defects
研究概览
简要总结
Primary Objective:
To estimate the overall combined rate of major structural birth defects in infants of mothers with atherosclerotic cardiovascular disease (ASCVD) and/or familial hypercholesterolemia (FH) exposed to Praluent® (alirocumab) during pregnancy when used to treat hypercholesterolemia and to compare that rate to unexposed disease-matched and unexposed non-diseased comparison pregnancies.
Secondary Objectives:
- Secondary objectives are to estimate the rates of the outcomes in pregnancies/infants of mothers with atherosclerotic cardiovascular disease and/or familial hypercholesterolemia exposed to alirocumab during pregnancy when used to treat hypercholesterolemia and to compare that rate to unexposed disease-matched and non-diseased comparison pregnancies, and secondarily to compare the rates of these outcomes in the unexposed disease-matched pregnancies to the rates in the unexposed non-diseased comparison pregnancies.
- Safety and tolerability of alirocumab.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Cohort 1 : alirocumab exposed
Pregnant women diagnosed with primary hypercholesterolemia and atherosclerotic cardiovascular disease, or primary hypercholesterolemia associated with familial hypercholesterolemia and exposed to alirocumab during the current pregnancy.
干预措施: ALIROCUMAB SAR236553 (REGN727) (Drug)
结局指标
主要结局
Rate of major structural birth defects
时间窗: Up to 1 year of age of the infant
Overall combined rate of major structural birth defects in infants born to females with atherosclerotic cardiovascular disease (ASCVD) and/or familial hypercholesterolemia (FH) exposed to Praluent (alirocumab)
次要结局
- Infant outcome: serious infections or hospitalizations, adverse reactions to childhood vaccinations(Up to 5 years of age of the child)
- Infant outcome: adequacy of immune response(Up to 5 years of age of the child)
- Adverse events(Up to 5 years follow-up period)
- Infant outcome: adverse neurodevelopment(Up to 5 years of age of the child)
- Breastfeeding/Lactation outcome(Up to 2 years of age of the child)
- Pregnancy outcome: Spontaneous abortion(Date of conception to 20 weeks gestation)
- Pregnancy outcome: Elective abortion(Date of conception to 20 weeks gestation)
- Pregnancy outcome: Still birth(At birth)
- Pregnancy outcome: Preterm delivery(Live birth prior to 37 weeks gestation)
- Infant outcome: Pattern of minor structural birth defects(Up to 1 year of age of the infant)
- Infant outcome: Small for gestational age(At birth)
- Infant outcome: Postnatal growth deficiency(Up to 1 year of age of the infant)