TEGSEDI Pregnancy Surveillance Program

  • STATUS
    Recruiting
  • End date
    Nov 15, 2030
  • participants needed
    20
  • sponsor
    Akcea Therapeutics
Updated on 19 February 2024

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.

Details
Condition Pregnancy, Pregnancy, Hereditary Transthyretin-mediated Amyloidosis With Polyneropathy
Age 100 years and younger
Treatment inotersen
Clinical Study IdentifierNCT04270058
SponsorAkcea Therapeutics
Last Modified on19 February 2024

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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