TEGSEDI Pregnancy Surveillance Program

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.

Full Title of Study: “Pregnancy Surveillance Program of Women and Infants Exposed to TEGSEDI During Pregnancy”

Study Type

  • Study Type: Observational [Patient Registry]
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: November 15, 2030

Interventions

  • Drug: inotersen
    • TEGSEDI injection, for subcutaneous use

Arms, Groups and Cohorts

  • Cohort 1
    • Cohort 1 will be pregnant patients who have been exposed to at least 1 dose of TEGSEDI within 25 weeks prior to conception or during pregnancy.
  • Cohort 2
    • Cohort 2 will be pregnant patients who have hATTR-PN, who were not exposed to TEGSEDI or have not received TEGSEDI within the previous 25 weeks prior to conception.

Clinical Trial Outcome Measures

Primary Measures

  • 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

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Akcea Therapeutics
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Amy Miller, RPh, Pharm D., 877-465-7510, tegsedipregnancy@ubc.com

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