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Recruiting
NCT05040373
Patisiran-Lipid Nanoparticle (LNP) Pregnancy Surveillance Program
Conditions: Hereditary Transthyretin-mediated (hATTR) Amyloidosis, Polyneuropathy
Sex: Female
Healthy volunteers: No
Enrollment: 10
Sponsor: Alnylam Pharmaceuticals
Location: Clinical Trial Site Iowa City Iowa
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.
Eligibility Criteria
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
* 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.
Source: ClinicalTrials.gov (NCT05040373). StuddyBuddy aggregates publicly available trial information.