[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100442360":3},{"organization":4,"outcomesModule":7,"designInfo":24,"detailedDescription":23,"studyPopulation":27,"armGroups":28,"interventions":23,"overallOfficials":32,"centralContacts":36,"locations":44,"responsibleParty":113,"collaborators":23,"id":115,"slug":116,"hasResults":117,"nctId":118,"briefTitle":119,"officialTitle":120,"acronym":23,"eligibilityCriteria":121,"healthyVolunteers":117,"sex":122,"minAge":23,"maxAge":23,"enrollmentInfo":123,"targetDuration":23,"studyType":126,"phases":23,"briefSummary":127,"conditions":128,"keywords":131,"overallStatus":47,"whyStopped":23,"lastUpdateSubmitDate":137,"lastUpdatePostDateStruct":138,"startDateStruct":141,"completionDateStruct":143,"leadSponsor":145,"locationsCount":146},{"fullName":5,"class":6},"Alnylam Pharmaceuticals","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":23},[9],{"measure":10,"description":11,"timeFrame":12},"Prevalence of Major Congenital Malformations","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.","From 12 weeks prior to last dose of patisiran through one year after birth (Up to 21 months)",[14,17,20],{"measure":15,"description":16,"timeFrame":12},"Prevalence of Minor Congenital Malformations","Minor congenital malformations will be classified classified according to the EUROCAT and MACDP classification systems.",{"measure":18,"description":19,"timeFrame":12},"Prevalence of Pregnancy Outcomes","Pregnancy outcomes are defined as live birth, spontaneous abortions, stillbirths, elective abortions, molar or pregnancy, ectopic pregnancy, preterm births, and maternal death.",{"measure":21,"description":22,"timeFrame":12},"Prevalence of Other Adverse Fetal\u002FNeonatal\u002FInfant Outcomes","Other adverse fetal\u002Fneonatal\u002Finfant outcomes are defined as low birth weight, failure to thrive, small for gestational age, postnatal growth and development, neonatal, and perinatal, or infant death.",null,{"allocation":23,"interventionModel":23,"interventionModelDescription":23,"primaryPurpose":23,"observationalModel":25,"timePerspective":26,"maskingInfo":23},"COHORT","PROSPECTIVE","Any woman exposed to patisiran-LNP 12 weeks prior to their last menstrual period (LMP) or at any time during pregnancy.",[29],{"label":30,"type":23,"description":31,"interventionNames":23},"Patisiran","Pregnant women exposed to commercial patisiran-LNP (ONPATTRO) during the 12 weeks prior to their last menstrual period (LMP) or at any time during pregnancy.",[33],{"name":34,"affiliation":5,"role":35},"Medical Director","STUDY_DIRECTOR",[37,42],{"name":38,"role":39,"phone":40,"phoneExt":23,"email":41},"Alnylam Clinical Trial Information Line","CONTACT","1-877-ALNYLAM","clinicaltrials@alnylam.com",{"name":38,"role":39,"phone":43,"phoneExt":23,"email":41},"1-877-256-9526",[45,59,68,77,86,95,104],{"facility":46,"status":47,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":23},"Clinical Trial Site","RECRUITING","Iowa City","Iowa","52242","United States","US",{"type":54,"coordinates":55},"Point",[56,57],-91.53017,41.66113,{"lat":57,"lon":56},{"facility":46,"status":47,"city":60,"state":23,"zip":23,"country":61,"countryCode":62,"cosmosGeoPoint":63,"geoPoint":67,"contacts":23},"Nantes","France","FR",{"type":54,"coordinates":64},[65,66],-1.55336,47.21725,{"lat":66,"lon":65},{"facility":46,"status":47,"city":69,"state":23,"zip":23,"country":70,"countryCode":71,"cosmosGeoPoint":72,"geoPoint":76,"contacts":23},"Münster","Germany","DE",{"type":54,"coordinates":73},[74,75],7.62571,51.96236,{"lat":75,"lon":74},{"facility":46,"status":47,"city":78,"state":23,"zip":23,"country":79,"countryCode":80,"cosmosGeoPoint":81,"geoPoint":85,"contacts":23},"Pavia","Italy","IT",{"type":54,"coordinates":82},[83,84],9.15917,45.19205,{"lat":84,"lon":83},{"facility":46,"status":47,"city":87,"state":23,"zip":23,"country":88,"countryCode":89,"cosmosGeoPoint":90,"geoPoint":94,"contacts":23},"Groningen","Netherlands","NL",{"type":54,"coordinates":91},[92,93],6.56667,53.21917,{"lat":93,"lon":92},{"facility":46,"status":47,"city":96,"state":23,"zip":23,"country":97,"countryCode":98,"cosmosGeoPoint":99,"geoPoint":103,"contacts":23},"Lisbon","Portugal","PT",{"type":54,"coordinates":100},[101,102],-9.1498,38.72509,{"lat":102,"lon":101},{"facility":46,"status":47,"city":105,"state":23,"zip":23,"country":106,"countryCode":107,"cosmosGeoPoint":108,"geoPoint":112,"contacts":23},"Madrid","Spain","ES",{"type":54,"coordinates":109},[110,111],-3.70256,40.4165,{"lat":111,"lon":110},{"type":114,"investigatorFullName":23,"investigatorTitle":23,"investigatorAffiliation":23,"oldNameTitle":23,"oldOrganization":23},"SPONSOR","100442360","patisiran-lipid-nanoparticle-lnp-pregnancy-surveillance-program-100442360",false,"NCT05040373","Patisiran-Lipid Nanoparticle (LNP) Pregnancy Surveillance Program","Patisiran-LNP Pregnancy Surveillance Program","Inclusion Criteria:\n\n* Documentation that the patient was exposed to patisiran-LNP at any point starting from 12 weeks before LMP or at any point during pregnancy\n* Germany Only: Patients must be treated per the summary of product characteristics (SmPC) for any approved treatment for ATTR amyloidosis\n\nExclusion Criteria:\n\n* There are no exclusion criteria for participation in this program.","FEMALE",{"count":124,"type":125},10,"ESTIMATED","OBSERVATIONAL","The purpose of this study is to collect and evaluate pregnancy outcomes, pregnancy complications, and fetal\u002Fneonatal\u002Finfant outcomes in women exposed to patisiran-LNP.",[129,130],"Hereditary Transthyretin-mediated (hATTR) Amyloidosis","Polyneuropathy",[132,133,134,135,136],"Hereditary neuropathic amyloidosis","Familial amyloidosis","Amyloidosis","Amyloidosis senile","Cardiac amyloidosis","2026-10-07",{"date":139,"type":140},"2026-10-08","ACTUAL",{"date":142,"type":140},"2020-08-01",{"date":144,"type":125},"2030-10-12",{"name":5,"class":6},7]