Rezdiffra Pregnancy and Lactation Registry
Recruiting · NCT07541469 · Observational (researchers observe without assigning treatment) · Lead sponsor: Madrigal Pharmaceuticals, Inc.
View the official record on ClinicalTrials.gov →Interventions studied
Rezdiffra
What this trial is about
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.
Who can take part
Age range
No age limits stated
Sex
Female
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- 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 criteria
- NONE
Where it is running
1 location listed across 1 US state.
- Madrigal Pharmaceuticals - West Conshohocken, Pennsylvania, United States