Patisiran-Lipid Nanoparticle (LNP) Pregnancy Surveillance Program

Conditions

• Hereditary Transthyretin-mediated (hATTR) Amyloidosis
• Polyneuropathy

Eligibility Criteria

Sex

FEMALE

Age

N/A - N/A

Healthy Volunteers

Not accepted

Study Details

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.

Key Dates

First listed

Sep 10, 2021

Start date

Aug 1, 2020

Status verified

May 2026

Primary completion

Oct 12, 2030

Completion

Oct 12, 2030

Study Design

Enrollment

10 participants (estimated)

Arms

• Arm: Patisiran
  Pregnant women exposed to commercial patisiran-LNP (ONPATTRO) during the 12 weeks prior to their last menstrual period (LMP) or at any time during pregnancy.

Primary Outcome Measure

Prevalence of Major Congenital Malformations [ Time Frame: From 12 weeks prior to last dose of patisiran through one year after birth (Up to 21 months) ]

Central Contacts

• Alnylam Clinical Trial Information Line
  1-877-ALNYLAM
  [email protected]
• Alnylam Clinical Trial Information Line
  1-877-256-9526
  [email protected]

Locations (1)

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