Rezdiffra Pregnancy and Lactation Registry
Sponsored by Madrigal Pharmaceuticals, Inc.
About this study
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.
Where this study is enrolling
- I'm interested
Madrigal Pharmaceuticals
West Conshohocken, Pennsylvania
Who can participate
Inclusion criteria
- ✓1. 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).
- ✓2. 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.
Only the research team can confirm whether you qualify. The intake questionnaire is the best way to find out.
Completing a questionnaire on Clinably does not enroll you in a clinical trial or confirm your eligibility. Only the research team can determine whether you qualify to participate. These results are based on the information you provide and are intended to help you start a conversation with the research team.
Trial data sourced from ClinicalTrials.gov.