Rezdiffra Pregnancy and Lactation Registry
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
AgeNot listed
SponsorMadrigal Pharmaceuticals, Inc.
About this trial
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.
Eligibility criteria
Qualifiers
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).
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.
Disqualifiers
None
Trial design
Treatments tested in this trial
- Rezdiffra
Treatment groups
No treatment groups listed
Locations
1Madrigal Pharmaceuticals19428, West ConshohockenPennsylvania, United States
Sponsors and collaborators
Madrigal Pharmaceuticals, Inc.
Lead sponsor
Source ClinicalTrials.gov