The purpose of this study is to collect and evaluate pregnancy outcomes, pregnancy complications, and fetal/neonatal/infant outcomes in women exposed to patisiran-LNP.
Eligibility
Sex
FEMALE
Min age
—
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Documentation that the patient was exposed to patisiran-LNP at any point starting from 12 weeks before LMP or at any point during pregnancy
* Germany Only: Patients must be treated per the summary of product characteristics (SmPC) for any approved treatment for ATTR amyloidosis
Exclusion Criteria:
* There are no exclusion criteria for participation in this program.
Primary outcome measure(s)
Prevalence of Major Congenital Malformations — From 12 weeks prior to last dose of patisiran through one year after birth (Up to 21 months) Major congenital malformations will be classified according to the European Concerted Action on Congenital Anomalies and Twins (EUROCAT) and Metropolitan Atlanta Congenital Defects Program (MACDP) classification systems.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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