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RecruitingNCT07205666

The Eplontersen Pregnancy and Lactation Outcomes Study

The Eplontersen Pregnancy and Lactation Outcomes Study (EPPRO): A Descriptive Safety Study of Pregnant and Lactating Individuals and Their Offspring Exposed to Eplontersen

Sponsor

AstraZeneca

Enrollment

10 participants

Start Date

Nov 30, 2025

Study Type

OBSERVATIONAL

Conditions

Transthyretin Amyloidosis

Summary

The overall objective of this DPSS is to describe the occurrence of pregnancy and maternal complications, adverse effects on the developing fetus and neonate, and adverse effects on the infant associated with exposure to eplontersen during pregnancy and/or lactation.

Eligibility

Inclusion Criteria2

  • all pregnancy and/or lactation cases with exposure to eplontersen and a diagnosis of an approved indication for treatment with eplontersen
  • all adverse event reports in infants in the first 12 months of age that are or can be linked to pregnancy or lactation reports in individuals previously diagnosed with an approved indication and exposed to eplontersen during pregnancy or lactaction

Exclusion Criteria1

  • all case reports considered invalid (i.e. minimum data is not provided at first report nor follow-up), or where reporter indicates that they do not wish to be contacted to obtain follow-up information, or the reporter/patient cannot be identified
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Locations(1)

Research Site

Frankfurt, Germany

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NCT07205666

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