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
- Groningen, NetherlandsSee the site
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The program follows women who took patisiran-LNP before or during pregnancy. It collects pregnancy, birth and baby outcomes.
- Sex
- Women only.
- Earlier treatment
- The patient was exposed to patisiran-LNP at any time from 12 weeks before the last menstrual period (LMP), or at any time during pregnancy. In Germany only, patients must be treated as set out in the summary of product characteristics (SmPC) for an approved ATTR amyloidosis treatment.
Read by machine on 12 November 2026.
Where in Netherlands
- GroningenHospital not named in the registryTaking 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?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial 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.