Status:
RECRUITING
The Eplontersen Pregnancy and Lactation Outcomes Study
Lead Sponsor:
AstraZeneca
Collaborating Sponsors:
ICON plc
Conditions:
Transthyretin Amyloidosis
Eligibility:
All Genders
Brief Summary
The overall objective of this DPSS is to describe the occurrence of pregnancy and maternal complications, adverse effects on the developing fetus and neonate, and adverse effects on the infant associa...
Detailed Description
Currently, there are no clinical studies of eplontersen use in pregnant individuals. Although it is expected that exposure to eplontersen during pregnancy or lactation is very rare, it is important to...
Eligibility Criteria
Inclusion
- all pregnancy and/or lactation cases with exposure to eplontersen and a diagnosis of an approved indication for treatment with eplontersen
- all adverse event reports in infants in the first 12 months of age that are or can be linked to pregnancy or lactation reports in individuals previously diagnosed with an approved indication and exposed to eplontersen during pregnancy or lactaction
Exclusion
- all case reports considered invalid (i.e. minimum data is not provided at first report nor follow-up), or where reporter indicates that they do not wish to be contacted to obtain follow-up information, or the reporter/patient cannot be identified
Key Trial Info
Start Date :
November 30 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 30 2035
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT07205666
Start Date
November 30 2025
End Date
December 30 2035
Last Update
December 18 2025
Active Locations (1)
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1
Research Site
Frankfurt, Germany