Status:
NOT_YET_RECRUITING
TEGSEDI Pregnancy Surveillance Program
Lead Sponsor:
Akcea Therapeutics
Conditions:
Hereditary Transthyretin-mediated Amyloidosis With Polyneropathy
Pregnancy
Eligibility:
FEMALE
Brief 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 ou...
Eligibility Criteria
Inclusion
- TEGSEDI exposed patients (Cohort 1) meeting the following criteria will be eligible for study entry:
- Pregnancies exposed to at least 1 dose of TEGSEDI within 25 weeks prior to conception or during pregnancy.
- Able and willing to provide informed consent.
- Unexposed patients (Cohort 2) meeting the following criteria will be eligible for study entry:
- Have a diagnosis of hATTR-PN during pregnancy.
- Have not been exposed to TEGSEDI within 25 weeks prior to conception or during pregnancy.
- Able and willing to provide informed consent.
Exclusion
- None
Key Trial Info
Start Date :
December 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
November 15 2030
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04270058
Start Date
December 1 2025
End Date
November 15 2030
Last Update
August 19 2025
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