Clinical Trial

TEGSEDI Pregnancy Surveillance Program

Not Yet Recruiting
View on ClinicalTrials.gov →
Summary
This is a worldwide safety surveillance study of pregnancy outcomes in women with hATTR-PN who may have been exposed or were not exposed to TEGSEDI prior to or during the pregnancy and of pediatric outcomes up to 1 year of age.
Protocol Amendment History 8 amendments
This ClinicalTrials.gov record has been amended 8 times since 2020-02-12; most recent amendment 2025-08-14.
Status change: Recruiting → Not Yet Recruiting 2025-08-14
Trial Details
NCT Number NCT04270058
Lead Sponsor Akcea Therapeutics
Conditions Hereditary Transthyretin-mediated Amyloidosis With Polyneropathy, Pregnancy
Enrollment 20 participants
Start Date 2025-12
Primary Completion 2030-11-15 (estimated)
Study Completion 2030-11-15 (estimated)
Updated on ClinicalTrials.gov 2025-08-19