NCT05040373招募中不适用
Patisiran-LNP Pregnancy Surveillance Program
Alnylam Pharmaceuticals8 个研究点 分布在 7 个国家目标入组 10 人开始时间: 2020年8月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 10
- 试验地点
- 8
- 主要终点
- Prevalence of Major Congenital Malformations
研究概览
简要总结
The purpose of this study is to collect and evaluate pregnancy outcomes, pregnancy complications, and fetal/neonatal/infant outcomes in women exposed to patisiran-LNP.
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
- 否
入选标准
- •Documentation that the patient was exposed to patisiran-LNP at any point starting from 12 weeks before LMP or at any point during pregnancy
- •Germany Only: Patients must be treated per the summary of product characteristics (SmPC) for any approved treatment for ATTR amyloidosis
排除标准
- •There are no exclusion criteria for participation in this program.
研究组 & 干预措施
Patisiran
Pregnant women exposed to commercial patisiran-LNP (ONPATTRO) during the 12 weeks prior to their last menstrual period (LMP) or at any time during pregnancy.
结局指标
主要结局
Prevalence of Major Congenital Malformations
时间窗: From 12 weeks prior to last dose of patisiran through one year after birth (Up to 21 months)
Major congenital malformations will be classified according to the European Concerted Action on Congenital Anomalies and Twins (EUROCAT) and Metropolitan Atlanta Congenital Defects Program (MACDP) classification systems.
次要结局
- Prevalence of Minor Congenital Malformations(From 12 weeks prior to last dose of patisiran through one year after birth (Up to 21 months))
- Prevalence of Pregnancy Outcomes(From 12 weeks prior to last dose of patisiran through one year after birth (Up to 21 months))
- Prevalence of Other Adverse Fetal/Neonatal/Infant Outcomes(From 12 weeks prior to last dose of patisiran through one year after birth (Up to 21 months))
研究者
研究点 (8)
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