A Phase 4, Decentralized Observational Registry to Evaluate the Safety in Women With NASH and Their Infants Exposed to REZDIFFRA™ (Resmetirom) During Pregnancy and/or Lactation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Pregnancy and Infant Outcomes Among Women Exposed to Rezdiffra During Pregnancy and/or Lactation
研究概览
简要总结
To evaluate pregnancy and clinical outcomes in women with NASH and their infants after exposure to Rezdiffra at any time during pregnancy and/or lactation.
详细描述
The purpose of the Rezdiffra™ Pregnancy and Lactation Registry is to create a worldwide information source, called a pregnancy registry. The registry will collect information about the safety of Rezdiffra™ (resmetirom), an approved medication, during pregnancy and/or while breastfeeding. This will help doctors and other healthcare providers learn more about its effect on pregnant and breastfeeding women and their infant after delivery up to 12 months of age.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female patients with NASH who have been exposed to at least 1 dose of resmetirom at any time during pregnancy (defined as having received resmetirom within 3 days prior to the date of conception and/or during pregnancy) and/or during lactation, and their infants (up to 12 months of age).
- •Patient or parent/legally authorized representative must be able to understand and provide consent through an Institutional Review Board/Independent Ethics Committee (IRB/IEC)-approved informed consent or assent form.
排除标准
- 未提供
结局指标
主要结局
Pregnancy and Infant Outcomes Among Women Exposed to Rezdiffra During Pregnancy and/or Lactation
时间窗: From enrollment through pregnancy and up to 12 months of infant age (participant observational period up to approximately 21 months)
To evaluate pregnancy and infant outcomes among women with NASH exposed to Rezdiffra during pregnancy and/or lactation, including pregnancy outcomes, congenital malformations, and infant growth, development, and safety outcomes.
次要结局
未报告次要终点