Actively Recruiting
Patisiran-Lipid Nanoparticle (LNP) Pregnancy Surveillance Program
Led by Alnylam Pharmaceuticals · Updated on 2026-06-01
10
Participants Needed
7
Research Sites
N/A
Total Duration
On this page
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Documentation that the patient was exposed to patisiran-LNP at any point starting from 12 weeks before last menstrual period or at any point during pregnancy
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 21 months from 12 weeks prior to last dose through one year after birth
Participants who were exposed to patisiran-LNP during pregnancy or in the 12 weeks prior are observed for pregnancy and infant outcomes.
Periodic visits based on pregnancy and infant assessments
Trial Site Locations
Total: 7 locations
1
Clinical Trial Site
Iowa City, Iowa, United States, 52242
Actively Recruiting
2
Clinical Trial Site
Nantes, France
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3
Clinical Trial Site
Münster, Germany
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4
Clinical Trial Site
Pavia, Italy
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5
Clinical Trial Site
Groningen, Netherlands
Actively Recruiting
6
Clinical Trial Site
Lisbon, Portugal
Actively Recruiting
7
Clinical Trial Site
Madrid, Spain
Actively Recruiting
Research Team
A
Alnylam Clinical Trial Information Line
A
Alnylam Clinical Trial Information Line
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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