Recruiting NCT05040373
Patisiran-Lipid Nanoparticle (LNP) Pregnancy Surveillance Program
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Hereditary Transthyretin-mediated (hATTR) Amyloidosis, Polyneuropathy. Basic parameters: No limits · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, France, Germany, Italy, Netherlands +2
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Patisiran-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.
Primary outcome 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)]
Secondary outcome measures (3)
- 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)]
- Prevalence of Pregnancy Outcomes [Time frame: From 12 weeks prior to last dose of patisiran through one year after birth (Up to 21 months)]
- 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)]
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
Exclusion criteria
- There are no exclusion criteria for participation in this program.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Clinical Trial Site — Iowa City
France · 1 center
- Clinical Trial Site — Nantes
Germany · 1 center
- Clinical Trial Site — Münster
Italy · 1 center
- Clinical Trial Site — Pavia
Netherlands · 1 center
- Clinical Trial Site — Groningen
Portugal · 1 center
- Clinical Trial Site — Lisbon
Spain · 1 center
- Clinical Trial Site — Madrid
Identifiers
NCT: NCT05040373 · ALN-TTR02-010