Clinical Trial
Study Details
Status
RECRUITING
Study ID #
NCT05040373
Study Start
Primary Completion
Study Completion
Enrollment
10
Study Type
Observational
Primary Outcomes
Measure
Prevalence of Major Congenital Malformations
Description

Major congenital malformations will be classified according to the European Concerted Action on Congenital Anomalies and Twins (EUROCAT) and Metropolitan Atlanta Congenital Defects Program (MACDP) classification systems.

Timeframe
From 12 weeks prior to last dose of patisiran through one year after birth (Up to 21 months)
Secondary Outcomes
Measure
Prevalence of Minor Congenital Malformations
Description

Minor congenital malformations will be classified classified according to the EUROCAT and MACDP classification systems.

Timeframe
From 12 weeks prior to last dose of patisiran through one year after birth (Up to 21 months)
Measure
Prevalence of Pregnancy Outcomes
Description

Pregnancy outcomes are defined as live birth, spontaneous abortions, stillbirths, elective abortions, molar or pregnancy, ectopic pregnancy, preterm births, and maternal death.

Timeframe
From 12 weeks prior to last dose of patisiran through one year after birth (Up to 21 months)
Measure
Prevalence of Other Adverse Fetal/Neonatal/Infant Outcomes
Description

Other adverse fetal/neonatal/infant outcomes are defined as low birth weight, failure to thrive, small for gestational age, postnatal growth and development, neonatal, and perinatal, or infant death.

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

Conditions
Hereditary Transthyretin-mediated (hATTR) Amyloidosis
Polyneuropathy
Study Contact
Name
Alnylam Clinical Trial Information Line
Role
Contact
Phone
1-877-ALNYLAM
Email
clinicaltrials@alnylam.com
Name
Alnylam Clinical Trial Information Line
Role
Contact
Phone
1-877-256-9526
Email
clinicaltrials@alnylam.com
Facility

Clinical Trial Site
Iowa City, IA 52242
United States

Facility

Clinical Trial Site
Nantes
France

Facility

Clinical Trial Site
Münster
Germany

Facility

Clinical Trial Site
Pavia
Italy

Facility

Clinical Trial Site
Groningen
Netherlands

Facility

Clinical Trial Site
Lisboa
Portugal

Facility

Clinical Trial Site
Madrid
Spain

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.

Sexes Eligible for Study
FEMALE
Eligibility Std Ages
Child
Adult
Older Adult
Study Population

Any woman exposed to patisiran-LNP 12 weeks prior to their last menstrual period (LMP) or at any time during pregnancy.

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