The Eplontersen Pregnancy and Lactation Outcomes Study

Recruiting now

Conditions studied: Transthyretin Amyloidosis

In brief

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 associated with exposure to eplontersen during pregnancy and/or lactation.

Key facts

Study ID

NCT07205666

Run by

AstraZeneca

People needed

10

Starts

2025-11-30

Expected to finish

2035-12-30

Last updated by the study team

2026-06-22

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Research Site — Frankfurt, Germany (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.