A Multinational Observational Study to Evaluate the Safety of Repatha® in Pregnancy
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Amgen
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Any incident of congenital anomaly
研究概览
简要总结
To evaluate pregnancy and infant outcomes among females diagnosed with familial hypercholesterolaemia (FH), exposed to Repatha® during pregnancy. This includes follow-up of their infants to the age of 12 months
详细描述
Women diagnosed with familial hypercholesterolaemia (FH), treated at centres in Europe, South Africa and Australia, with pregnancy confirmed during the study observation period and who provide informed consent to participate in the study.
Exposed subjects are women who received Repatha® during pregnancy and/or breastfeeding; unexposed subjects are women who have not received Repatha® during pregnancy and/or breast-feeding. In infants, exposure may occur in utero and/or via breast milk, within 15 weeks following the date of Repatha® dosing in the mother
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Females diagnosed with Familial hypercholesterolaemia (FH).
- •Confirmed pregnancy during the study observation period.
- •Pregnancies identified retrospectively but within the study period will be included
- •Multiple pregnancies, occurring in the same woman within the study period, will all be included (as separate pregnancies)
- •Provided informed consent to follow-up in this study, for subject and their infant(s) born during the study observation period
排除标准
- •There are no exclusion criteria
结局指标
主要结局
Any incident of congenital anomaly
时间窗: From birth up to 12 months of age
Any incidence of congenital anomaly recorded on the study specific eCRF
次要结局
- Status of infant at delivery(At delivery)
- Mode of delivery of infant(At delivery)
- Details of any chronic medication taken by infant from birth to 12 months of age(From birth to 12 months of age)
- Details of any hospitalisations of infant, documented from delivery to 12 months of age.(From delivery to 12 months of age)
- End product of pregnancy summarised within 3 main categories: Fetal death, termination of pregnancy and live birth(From pregnancy diagnosis through to birth)
- Growth of infant at 6 months post delivery(Between birth and 6 months of age)
- Developmental milestones measured at 6 and 12 months of age(At 6 and 12 months of age of infant)
- Details of any complication of delivery(At delivery)
- Growth of infant at 12 months post delivery(Between birth and 12 months of age)