Actively Recruiting
The Eplontersen Pregnancy and Lactation Outcomes Study
Led by AstraZeneca · Updated on 2026-05-01
10
Participants Needed
1
Research Sites
526 weeks
Total Duration
On this page
Sponsors
A
AstraZeneca
Lead Sponsor
I
ICON plc
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
The Eplontersen Pregnancy and Lactation Outcomes Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pregnancy and/or lactation cases with exposure to eplontersen and a diagnosis of an approved indication for treatment with eplontersen
- Adverse event reports in infants under 12 months of age linked to pregnancy or lactation exposure to eplontersen in individuals diagnosed with an approved indication
You will not qualify if you...
- Case reports lacking minimum data at first report and follow-up
- Cases where the reporter does not wish to be contacted for follow-up
- Cases where the reporter or patient cannot be identified
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Research Site
Frankfurt, Germany
Actively Recruiting
Research Team
A
AstraZeneca Clinical Study Information Center
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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