Observational Study on Safety of Rezdiffra Resmetirom Use in Women with NASH During Pregnancy and Breastfeeding and Their Infants

What this Trial Is About

This observational registry is designed to collect information on pregnancy and clinical outcomes in women with metabolic dysfunction-associated steatohepatitis NASH who have been exposed to Rezdiffra resmetirom during pregnancy andor lactation. The study aims to understand how this medication affects both the women and their infants up to 12 months after birth, providing valuable safety data for healthcare providers worldwide. Participants include women who have taken at least one dose of Rezdiffra around the time of conception, during pregnancy, or while breastfeeding. The registry observes these women and their infants without administering any new treatments or interventions. Data is gathered throughout pregnancy and continues until the infants reach one year of age. During the study, researchers collect detailed information about pregnancy outcomes and infant health through regular follow-ups lasting up to approximately 21 months total, from enrollment through pregnancy and infant age. This includes monitoring clinical outcomes related to the medication exposure, ensuring careful observation of both mother and child during this period.

Rezdiffra Pregnancy and Lactation Registry