Monitoring pregnancy outcomes in women exposed to patisiran-LNP

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational program aims to collect and evaluate pregnancy outcomes, complications, and fetal/neonatal/infant outcomes in women who have been exposed to patisiran-LNP. The study will gather data from participants who were exposed to the treatment starting from 12 weeks before their last menstrual period or at any point during their pregnancy. By analyzing this data, the program seeks to understand the safety and effects of patisiran-LNP during pregnancy.

Why it matters

Who can join: the full rules

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.

Where it's running

• Clinical Trial Site
  Iowa City, Iowa, United States 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

Study contacts

• Study coordinator: Alnylam Clinical Trial Information Line
• Email: clinicaltrials@alnylam.com
• Phone: 1-877-ALNYLAM

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.