Back to search results

Patisiran-LNP Pregnancy Surveillance Program for hATTR Amyloidosis

This observational study is looking at the effects of patisiran-LNP exposure during pregnancy. It aims to understand pregnancy outcomes, any complications, and the health of babies born to women who have been exposed to patisiran-LNP. You may be able to join if you are a woman who was exposed to patisiran-LNP at any point starting 12 weeks before your last menstrual period or at any time during your pregnancy. The main goal is to see how often major birth defects occur in babies whose mothers were exposed to patisiran-LNP. The study plans to enroll 10 participants, but its current status is unclear.

Study design
This is an observational study, not a treatment trial. It plans to enroll 10 women.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study will follow participants from 12 weeks before the last dose of patisiran through one year after the baby's birth (up to 21 months).

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05040373

Patisiran-Lipid Nanoparticle (LNP) Pregnancy Surveillance Program

Recruiting
Not specifiedAll AgesObservational
Alnylam Pharmaceuticals
~10 participants
Updated 2026-06-01 on ClinicalTrials.gov

At a glance

Recruiting sites
7 of 7 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Prevalence of Major Congenital Malformations
Measured over From 12 weeks prior to last dose of patisiran through one year after birth (Up to 21 months)

Conditions

Hereditary Transthyretin-mediated (hATTR) Amyloidosis
Polyneuropathy

Explore related trials

Cardiac AmyloidosisHereditary ATTR Amyloidosis

Where it's being run

7 sites across 7 states
Iowa1
France1
Germany1
Italy1
Netherlands1
Portugal1
Spain1

Study leadership

  • Medical Director · STUDY_DIRECTOR · Alnylam Pharmaceuticals

Who to contact

Alnylam Clinical Trial Information Line
[email protected]
1-877-ALNYLAM
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

Documentation that the patient was exposed to patisiran-LNP at any point starting from 12 weeks before LMP or at any point during pregnancy

What this trial measures

  • Prevalence of Major Congenital MalformationsFrom 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.