TEGSEDI Pregnancy Surveillance Program

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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Key information

Conditions

Hereditary Transthyretin-mediated Amyloidosis With Polyneropathy Amyloidosis, Hereditary, Transthyretin-Related Disease Attributes Pathologic Processes Pathological Conditions, Signs and Symptoms Pregnancy Rare Diseases

Sex eligibility

Female

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

inotersen

Drug

TEGSEDI injection, for subcutaneous use

Primary outcomes

Frequency of Selected Pregnancy and Fetal/Neonatal Outcomes

Time frame: 10 years or 12 months after the last live birth whichever is later
Estimate the frequency of selected pregnancy and fetal/neonatal outcomes through 1 year of age in women who were exposed to at least 1 dose of TEGSEDI (Cohort 1) within 25 weeks prior to conception or during pregnancy, with the exposure window of interest for major congenital malformations being the first trimester, and in the unexposed cohort of pregnant women (Cohort 2) who have a diagnosis of hereditary transthyretin amyloidosis with polyneuropathy (hATTR-PN)
- pregnancy outcomes include live births, spontaneous abortions, stillbirths, elective abortions, preterm birth
- fetal/neonatal outcomes include major and minor congenital malformations, small for gestational age, failure to thrive, and postnatal development
Frequency of Selected Pregnancy Complications

Time frame: 10 years or 12 months after the last live birth whichever is later

Estimate the frequency of selected pregnancy complications in women who were exposed to TEGSEDI (Cohort 1) within 25 weeks prior to conception or during pregnancy and in the unexposed cohort of pregnant women (Cohort 2) who have a diagnosis of hATTR-PN

Study contacts

Contact information is provided by the study sponsor or research team.

Ionis Pharmaceuticals

CONTACT

[email protected]

(844) 962-4787

Sponsors and collaborators

Lead sponsor

Akcea Therapeutics

Industry

Registry information

Official study title

Pregnancy Surveillance Program of Women and Infants Exposed to TEGSEDI During Pregnancy

Important dates

Study start: 2025
Primary completion: 2030
Study completion: 2030
First posted: Feb 17, 2020
Registry last updated: Aug 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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