Actively Recruiting
Observational Study on Pregnancy Outcomes in Women Exposed to Patisiran-Lipid Nanoparticle LNP
Led by Alnylam Pharmaceuticals · Updated on 2026-06-01
10
Participants Needed
7
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
This research aims to collect and evaluate pregnancy outcomes and complications in women exposed to patisiran-LNP, a treatment used for hereditary transthyretin-mediated hATTR amyloidosis and polyneuropathy. The study focuses on monitoring the effects on fetal, neonatal, and infant health after exposure during pregnancy. The program observes pregnant women who have taken commercial patisiran-LNP ONPATTRO either within 12 weeks before their last menstrual period LMP or at any time during pregnancy. There are no intervention groups or treatments assigned in this observational study, as it monitors outcomes related to prior exposure. Participants will be followed from the time of exposure through pregnancy and up to one year after birth, totaling up to 21 months. Researchers will track the prevalence of major and minor congenital malformations, pregnancy outcomes, and other adverse fetal, neonatal, or infant outcomes. The study gathers data to better understand the safety and effects of patisiran-LNP during pregnancy.
CONDITIONS
Brief Title
Patisiran-Lipid Nanoparticle (LNP) Pregnancy Surveillance Program
Research Team
A
Alnylam Clinical Trial Information Line
A
Alnylam Clinical Trial Information Line
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