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
Madrigal Pharmaceuticals, Inc.
Summary
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.
Description
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.
Eligibility
- Age range
- Not specified
- Sex
- Female
- Healthy volunteers
- Yes
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. Exclusion Criteria: NONE
Interventions
- DrugRezdiffra
Exposure to at least one dose of Resmetirom.
Location
- Madrigal PharmaceuticalsWest Conshohocken, Pennsylvania