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Patisiran-Lipid Nanoparticle (LNP) Pregnancy Surveillance Program

StatusRecruiting
PhaseNot specified
Started2020-08-01
View on ClinicalTrials.gov ↗

Amendment history

The 50 most recent of 54 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

2026-09-04
Study Identification, Study Status, Eligibility v53
Eligibility criteria+137 characters
[...] g from 12 weeks before LMP or at any point during pregnancy Germany Only: Patients must be treated per the summary of product characteristics (SmPC) for any approved treatment for ATTR amyloidosis Exclusion Criteria: There are no exclusion criteria for participation in this program.
2026-05-28
44 amendments v9-v52
44 re-verifications since 2022-06-02, no change to tracked fields
2022-05-12
Study Status, Contacts/Locations v8
Study sites4→7
2022-04-11
4 amendments v4-v7
4 re-verifications since 2022-01-12, no change to tracked fields
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.
Trial Details
NCT Number NCT05040373
Lead Sponsor Alnylam Pharmaceuticals
Conditions Hereditary Transthyretin-mediated (hATTR) Amyloidosis, Polyneuropathy
Enrollment 10 participants
Start Date 2020-08-01
Primary Completion 2030-10-12 (estimated)
Study Completion 2030-10-12 (estimated)
Updated on ClinicalTrials.gov 2026-09-08