Follows pregnancies in women exposed to patisiran for hereditary amyloidosis
Collects pregnancy and infant outcomes in women who received patisiran for hATTR amyloidosis.
Key facts
- Who runs it
- Alnylam Pharmaceuticals
- Where
- Münster, GermanySee the siteAlso in 6 other countries, 6 sites
- Trial code
- Registry title
- Patisiran-Lipid Nanoparticle (LNP) Pregnancy Surveillance Program
- Status
- Recruiting
- People taking part
- 10 people, planned
- Started
- 1 Aug 2020
- Expected to end
- 12 Oct 2030
- Type of study
- Observational
- Record updated
- 8 October 2026
Who can take part
AI summary
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.
The registry criteria, word for word
Show all 3 criteriaShow less
Who can take part
- 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
Who cannot take part
- There are no exclusion criteria for participation in this program
Where in Germany
Also in 6 other countries, 6 sites
- MünsterHospital not named in the registryTaking people
About the trial
What the trial wants to find out
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.
The group in the trial
- Patisiran
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.
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 doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Patisiran-LNP Pregnancy Surveillance Program
- Plain-language title
- Follows pregnancies in women exposed to patisiran for hereditary amyloidosisGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 8 October 2026