An observational study in Hereditary Transthyretin-mediated (hATTR) Amyloidosis and Polyneuropathy, sponsored by Alnylam Pharmaceuticals. Recruiting at 7 sites in 7 countries. Open to female participants. Per ClinicalTrials.gov, last updated 2026-10-08.
Sponsored by Alnylam Pharmaceuticals · Observational
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.
290 studies on the registry are indexed under Amyloidosis; 92 are open to participants now.
This study's planned enrollment of 10 is below the median of 190 across 83 observational studies indexed under Amyloidosis.
Browse Amyloidosis studies →Alnylam Pharmaceuticals is the lead sponsor of 84 studies on the registry; 19 are open to participants now.
Of its 18 completed or terminated interventional studies of FDA-regulated products, 15 (83%) have results posted.
Counted across the registry records on this site, refreshed daily.
Any woman exposed to patisiran-LNP 12 weeks prior to their last menstrual period (LMP) or at any time during pregnancy.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Pregnant women exposed to commercial patisiran-LNP (ONPATTRO) during the 12 weeks prior to their last menstrual period (LMP) or at any time during pregnancy.
Prevalence of Major Congenital Malformations
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.
Time frame: From 12 weeks prior to last dose of patisiran through one year after birth (Up to 21 months)
Prevalence of Minor Congenital Malformations
Minor congenital malformations will be classified classified according to the EUROCAT and MACDP classification systems.
Time frame: From 12 weeks prior to last dose of patisiran through one year after birth (Up to 21 months)
Prevalence of Pregnancy Outcomes
Pregnancy outcomes are defined as live birth, spontaneous abortions, stillbirths, elective abortions, molar or pregnancy, ectopic pregnancy, preterm births, and maternal death.
Time frame: From 12 weeks prior to last dose of patisiran through one year after birth (Up to 21 months)
Prevalence of Other Adverse Fetal/Neonatal/Infant Outcomes
Other adverse fetal/neonatal/infant outcomes are defined as low birth weight, failure to thrive, small for gestational age, postnatal growth and development, neonatal, and perinatal, or infant death.
Time frame: From 12 weeks prior to last dose of patisiran through one year after birth (Up to 21 months)
Plan to share: No
No publications or documents are linked to this record.
Started Aug 2020 (actual). Primary completion is estimated for Oct 2030, 122 months after the start.
Of 52 observational studies under Amyloidosis, half reached primary completion within 97 months of starting (the median), counting those still running; a quarter within 29 and three quarters within 183. This study's planned 122 months is above that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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