NCT05040373Recruiting
Patisiran-Lipid Nanoparticle (LNP) Pregnancy Surveillance Program
Patisiran-LNP Pregnancy Surveillance Program
Source: ClinicalTrials.gov · Last updated 8 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 10 (estimated)
- First submitted
- 14 Jul 2021
- Start date
- Aug 2020
- Primary completion date
- Oct 2030
- Lead sponsor
- Alnylam Pharmaceuticals
- Diseases
- Amyloidosis
- NCT number
- NCT05040373
What you commit to
- Study type: Observational
- Planned participants: 10
- From Aug 2020 to the primary completion date, Oct 2030
- 7 sites in 7 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- There are no exclusion criteria for participation in this program.
Who the study is looking for
- 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
Sex: Female · Does not accept healthy volunteers
Sites (7)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| - Coordinator of this site? Confirm its status | Münster | Germany | Recruiting |
| - Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| - Coordinator of this site? Confirm its status | Nantes | France | Recruiting |
| - Coordinator of this site? Confirm its status | Pavia | Italy | Recruiting |
| - Coordinator of this site? Confirm its status | Groningen | Netherlands | Recruiting |
| - Coordinator of this site? Confirm its status | Lisbon | Portugal | Recruiting |
| - Coordinator of this site? Confirm its status | Iowa City | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.