Studies safety of eplontersen in pregnant and breastfeeding people
Follows pregnant and breastfeeding people with transthyretin amyloidosis who take eplontersen.
Key facts
- Who runs it
- AstraZeneca
- Where
- Frankfurt, GermanySee the site
- Trial code
- Registry title
- The Eplontersen Pregnancy and Lactation Outcomes Study
- Status
- Recruiting
- People taking part
- 10 people, planned
- Started
- 30 Nov 2025
- Expected to end
- 30 Dec 2035
- Type of study
- Observational
- Record updated
- 27 August 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The study follows people who took eplontersen during pregnancy or breastfeeding for an approved use, and infants with health problems linked to it.
- Sex
- All sexes.
- Disease stage
- A diagnosis of an approved use for eplontersen.
- Earlier treatment
- Exposure to eplontersen during pregnancy or breastfeeding.
Main reasons for not taking part
- Case reports with too little data at first report or follow-up
- Reporter does not want to be contacted for follow-up
- Reporter or patient cannot be identified
The registry criteria, word for word
Show all 3 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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 in Germany
- FrankfurtHospital not named in the registryTaking people
About the trial
What the trial wants to find out
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.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- The Eplontersen Pregnancy and Lactation Outcomes Study (EPPRO): A Descriptive Safety Study of Pregnant and Lactating Individuals and Their Offspring Exposed to Eplontersen
- Plain-language title
- Studies safety of eplontersen in pregnant and breastfeeding peopleGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 27 August 2026