Pregnancy Surveillance Program of Women and Infants Exposed to TEGSEDI During Pregnancy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 20
- 主要终点
- Frequency of Selected Pregnancy and Fetal/Neonatal Outcomes
研究概览
简要总结
This is a worldwide safety surveillance study of pregnancy outcomes in women with hATTR-PN who may have been exposed or were not exposed to TEGSEDI prior to or during the pregnancy and of pediatric outcomes up to 1 year of age.
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
- •TEGSEDI exposed patients (Cohort 1) meeting the following criteria will be eligible for study entry:
- •Pregnancies exposed to at least 1 dose of TEGSEDI within 25 weeks prior to conception or during pregnancy.
- •Able and willing to provide informed consent.
- •Unexposed patients (Cohort 2) meeting the following criteria will be eligible for study entry:
- •Have a diagnosis of hATTR-PN during pregnancy.
- •Have not been exposed to TEGSEDI within 25 weeks prior to conception or during pregnancy.
- •Able and willing to provide informed consent.
排除标准
- 未提供
研究组 & 干预措施
Cohort 1
Cohort 1 will be pregnant patients who have been exposed to at least 1 dose of TEGSEDI within 25 weeks prior to conception or during pregnancy.
干预措施: inotersen (Drug)
结局指标
主要结局
Frequency of Selected Pregnancy and Fetal/Neonatal Outcomes
时间窗: 10 years or 12 months after the last live birth whichever is later
Estimate the frequency of selected pregnancy and fetal/neonatal outcomes through 1 year of age in women who were exposed to at least 1 dose of TEGSEDI (Cohort 1) within 25 weeks prior to conception or during pregnancy, with the exposure window of interest for major congenital malformations being the first trimester, and in the unexposed cohort of pregnant women (Cohort 2) who have a diagnosis of hereditary transthyretin amyloidosis with polyneuropathy (hATTR-PN) * pregnancy outcomes include live births, spontaneous abortions, stillbirths, elective abortions, preterm birth * fetal/neonatal outcomes include major and minor congenital malformations, small for gestational age, failure to thrive, and postnatal development
Frequency of Selected Pregnancy Complications
时间窗: 10 years or 12 months after the last live birth whichever is later
Estimate the frequency of selected pregnancy complications in women who were exposed to TEGSEDI (Cohort 1) within 25 weeks prior to conception or during pregnancy and in the unexposed cohort of pregnant women (Cohort 2) who have a diagnosis of hATTR-PN
次要结局
未报告次要终点