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TEGSEDI Pregnancy Surveillance Program

TEGSEDI Pregnancy Surveillance Program

Recruiting
100 years and younger
Female
Phase N/A

Overview

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.

Eligibility

Inclusion Criteria:

TEGSEDI exposed patients (Cohort 1) meeting the following criteria will be eligible for study entry:

  1. Pregnancies exposed to at least 1 dose of TEGSEDI within 25 weeks prior to conception or during pregnancy.
  2. Able and willing to provide informed consent.

Unexposed patients (Cohort 2) meeting the following criteria will be eligible for study

entry
  1. Have a diagnosis of hATTR-PN during pregnancy.
  2. Have not been exposed to TEGSEDI within 25 weeks prior to conception or during pregnancy.
  3. Able and willing to provide informed consent.

Exclusion Criteria:

None

Study details
    Pregnancy
    Pregnancy
    Hereditary Transthyretin-mediated Amyloidosis With Polyneropathy

NCT04270058

Akcea Therapeutics

16 February 2024

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