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
This trial accepts healthy volunteersQualifiers
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 population
The registry will allow healthcare providers (HCPs) to enroll eligible patients and will also allow eligible patients to self-enroll. The registry is voluntary.
Trial design
Design model
Other
Time perspective
Other
Treatments tested in this trial
Rezdiffra
DrugExposure to at least one dose of Resmetirom.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Pregnancy and Infant Outcomes Among Women Exposed to Rezdiffra During Pregnancy and/or Lactation
To evaluate pregnancy and infant outcomes among women with NASH exposed to Rezdiffra during pregnancy and/or lactation, including pregnancy outcomes, congenital malformations, and infant growth, development, and safety outcomes.
Time frame
From enrollment through pregnancy and up to 12 months of infant age (participant observational period up to approximately 21 months)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov