Follows pregnancies in women exposed to patisiran for hereditary amyloidosis
Collects pregnancy and infant outcomes in women who received patisiran for hATTR amyloidosis.
Plain-language title generated from the registry record
Registry title: Patisiran-Lipid Nanoparticle (LNP) Pregnancy Surveillance Program
Key facts
- Where
- Pavia, ItalySee the site
Where in Italy
- PaviaPavia, ItalyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Alnylam Pharmaceuticals
- Trial code
- NCT05040373
- Record updated
- 8 October 2026
- Original description
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.Read full original descriptionShow less
Patisiran-LNP Pregnancy Surveillance Program
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.
Inclusion: 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: There are no exclusion criteria for participation in this program.