Patisiran-Lipid Nanoparticle (LNP) Pregnancy Surveillance Program

Overview

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.

Full Title of Study: “Patisiran-LNP Pregnancy Surveillance Program”

Study Type

• Study Type: Observational
• Study Design
  • Time Perspective: Prospective
• Study Primary Completion Date: October 12, 2030

Arms, Groups and Cohorts

• 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.

Clinical Trial Outcome Measures

Primary Measures

• 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)
  • 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.

Secondary Measures

• Prevalence of Minor Congenital Malformations
  • Time Frame: From 12 weeks prior to last dose of patisiran through one year after birth (Up to 21 months)
  • Minor congenital malformations will be classified classified according to the EUROCAT and MACDP classification systems.
• Prevalence of Pregnancy Outcomes
  • Time Frame: From 12 weeks prior to last dose of patisiran through one year after birth (Up to 21 months)
  • Pregnancy outcomes are defined as live birth, spontaneous abortions, stillbirths, elective abortions, molar or pregnancy, ectopic pregnancy, preterm births, and maternal death.
• Prevalence of Other Adverse Fetal/Neonatal/Infant Outcomes
  • Time Frame: From 12 weeks prior to last dose of patisiran through one year after birth (Up to 21 months)
  • Other adverse fetal/neonatal/infant outcomes are defined as low birth weight, failure to thrive, small for gestational age, postnatal growth and development, neonatal, and perinatal, or infant death.

Participating in This Clinical Trial

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 Exclusion Criteria:

• There are no exclusion criteria for participation in this program.

Gender Eligibility: Female

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

• Lead Sponsor
  • Alnylam Pharmaceuticals
• Provider of Information About this Clinical Study
  • Sponsor
• Overall Official(s)
  • Medical Director, Study Director, Alnylam Pharmaceuticals
• Overall Contact(s)
  • Alnylam Clinical Trial Information Line, 1-877-ALNYLAM, clinicaltrials@alnylam.com