Eplontersen exposure during pregnancy and breastfeeding: outcomes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This descriptive pregnancy safety study compiles secondary data on people exposed to eplontersen during pregnancy or lactation using AstraZeneca's PV‑Argus database and a PRegnancy outcomes Intensive Monitoring (PRIM) pharmacovigilance approach. Eligible cases include reports from clinical trials, spontaneous post‑marketing submissions, observational studies, patient programs, published literature, and healthcare provider communications. Data are captured via a prespecified follow‑up schedule and questionnaires, and multiple attempts will be made to obtain missing information from reporters. The analysis will summarize maternal, fetal, neonatal, and infant outcomes associated with eplontersen exposure.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

* 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

Where it's running

• Research Site
  Frankfurt, Germany Recruiting

Study contacts

• Principal investigator: Myriam Alexander, PHD — AstraZeneca
• Study coordinator: AstraZeneca Clinical Study Information Center
• Email: information.center@astrazeneca.com
• Phone: 1-877-240-9479

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.