Patisiran-Lipid Nanoparticle (LNP) Pregnancy Surveillance Program

Alnylam Pharmaceuticals

Status: Enrolling

Conditions: Polyneuropathy; Hereditary Transthyretin-mediated (hATTR) Amyloidosis

Study type: Observational

Funder types: Industry

Identifiers

NCT05040373

ALN-TTR02-010

Details and patient eligibility

About

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.

Enrollment: 10 estimated patients

Sex: Female

Volunteers: No Healthy Volunteers

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.

Trial design

10 participants in 1 patient group

Patisiran

Description:

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.