NCT07205666Recruiting
The Eplontersen Pregnancy and Lactation Outcomes Study
The Eplontersen Pregnancy and Lactation Outcomes Study (EPPRO): A Descriptive Safety Study of Pregnant and Lactating Individuals and Their Offspring Exposed to Eplontersen
Source: ClinicalTrials.gov · Last updated 27 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 10 (estimated)
- First submitted
- 17 Sept 2025
- Start date
- 30 Nov 2025
- Primary completion date
- 30 Dec 2035
- Lead sponsor
- AstraZeneca
- Diseases
- Amyloidosis
- NCT number
- NCT07205666
What you commit to
- Study type: Observational
- Planned participants: 10
- From 30 Nov 2025 to the primary completion date, 30 Dec 2035
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- 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
Who the study is looking for
- 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
Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Research Site Coordinator of this site? Confirm its status | Frankfurt | Germany | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.