跳至主要内容
临床试验/NCT06302270
NCT06302270招募中不适用

Monitoring of Women and Children Exposed to the Combination of Elexacaftor-tezacaftor-ivacaftor During Bregnancy and Through Mother's Own Milk.

Region Stockholm1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2024年3月15日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
75
试验地点
1
主要终点
Health effects in the newborn infant

研究概览

简要总结

Observational study on women with Cystic Fibrosis treated with CFTR modulators during pregnancy and postpartum and their children. Registration on maternal health parameters and effects of CFTR-modulators in the newborn infant as well as effects of exposure through mother's own milk.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
— 至 50 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Woman with cystic fibrosis who is pregnant and treated with Kaftrio. Newborn infant to the above mentioned woman

排除标准

  • 未提供

结局指标

主要结局

Health effects in the newborn infant

时间窗: 6 years

次要结局

未报告次要终点

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验