RecruitingNCT07541469
Rezdiffra Pregnancy and Lactation Registry
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
Sponsor
Madrigal Pharmaceuticals, Inc.
Enrollment
10 participants
Start Date
Mar 4, 2026
Study Type
OBSERVATIONAL
Conditions
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.
Eligibility
Sex: FEMALE
Inclusion Criteria2
- 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.
Exclusion Criteria1
- NONE
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Interventions
DRUGRezdiffra
Exposure to at least one dose of Resmetirom.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07541469
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