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

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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