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.
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.
Study Type
OBSERVATIONAL
Enrollment
10
Exposure to at least one dose of Resmetirom.
Madrigal Pharmaceuticals
West Conshohocken, Pennsylvania, United States
RECRUITINGPregnancy and Infant Outcomes Among Women Exposed to Rezdiffra During Pregnancy and/or Lactation
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.
Time frame: From enrollment through pregnancy and up to 12 months of infant age (participant observational period up to approximately 21 months)
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