RecruitingNot Applicable

Patisiran-Lipid Nanoparticle (LNP) Pregnancy Surveillance Program

United States, France, Germany10 participantsStarted 2020-08-01

Plain-language summary

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.

Who can participate

SexFEMALE

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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.

What they're measuring

Prevalence of Major Congenital Malformations

Timeframe: From 12 weeks prior to last dose of patisiran through one year after birth (Up to 21 months)

Trial details

NCT IDNCT05040373

SponsorAlnylam Pharmaceuticals

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2030-10-12

Contact for this trial

Alnylam Clinical Trial Information Line

1-877-ALNYLAM clinicaltrials@alnylam.com

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