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Clinical Trials in the Netherlands / NCT05040373
Recruiting Observational

Patisiran-Lipid Nanoparticle (LNP) Pregnancy Surveillance Program

NCT05040373 · tracked via the Priya Life Science Netherlands tracker
Sponsor
Alnylam Pharmaceuticals
Phase
Observational
Started
2020-08-01
Last updated
2026-10-08

Condition(s) studied

Hereditary Transthyretin-mediated (hATTR) AmyloidosisPolyneuropathy

Study summary

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.

Eligibility

Sex
FEMALE
Min age
—
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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 Criteria: * There are no exclusion criteria for participation in this program.

Primary outcome measure(s)

  • Prevalence of Major Congenital Malformations — From 12 weeks prior to last dose of patisiran through one year after birth (Up to 21 months)
    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.

Trial sites (7)

FacilityCityRegionStatus
Clinical Trial Site Iowa City Iowa Recruiting
Clinical Trial Site Nantes France Recruiting
Clinical Trial Site Münster Germany Recruiting
Clinical Trial Site Pavia Italy Recruiting
Clinical Trial Site Groningen Netherlands Recruiting
Clinical Trial Site Lisbon Portugal Recruiting
Clinical Trial Site Madrid Spain Recruiting

More Alnylam Pharmaceuticals trials in the Netherlands

Zilebesiran in Patients With Hypertension Not Adequately Controlled and With Either Established Cardiovascular Disease or High Risk for Cardiovascular Disease Recruiting
A Study to Evaluate ALN-5288 in Patients With Alzheimer's Disease Recruiting
A Study to Evaluate Vutrisiran in Patients With Transthyretin Amyloidosis With Cardiomyopathy Enrolling by invitation
HMBeacon: A Phase 2 Study to Evaluate ALN-6400 in Adult and Adolescent Female Patients With VWD and HMB Recruiting
ConTTRibute: A Global Observational Study of Patients With Transthyretin (TTR)-Mediated Amyloidosis (ATTR Amyloidosis) Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05040373 on ClinicalTrials.gov ↗ ← All trials in the Netherlands