Transthyretin Amyloid Cardiomyopathy Clinical Trial

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TEGSEDI Pregnancy Surveillance Program

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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.

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Eligibility Criteria

Inclusion Criteria:

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 Criteria:

None

Study is for people with:

Transthyretin Amyloid Cardiomyopathy

Estimated Enrollment:

20

Study ID:

NCT04270058

Recruitment Status:

Recruiting

Sponsor:

Akcea Therapeutics

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There is 1 Location for this study

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TEGSEDI Pregnancy Coordinating Center
Morgantown West Virginia, 26508, United States More Info
Amy Miller, RPh, PharmD
Contact
877-465-7510
[email protected]

How clear is this clinincal trial information?

Study is for people with:

Transthyretin Amyloid Cardiomyopathy

Estimated Enrollment:

20

Study ID:

NCT04270058

Recruitment Status:

Recruiting

Sponsor:


Akcea Therapeutics

How clear is this clinincal trial information?

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