[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100588409":3},{"organization":4,"armGroups":7,"interventions":13,"overallOfficials":10,"centralContacts":19,"locations":25,"responsibleParty":77,"collaborators":79,"id":82,"slug":83,"hasResults":84,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":88,"eligibilityCriteria":89,"healthyVolunteers":84,"sex":90,"minAge":10,"maxAge":10,"enrollmentInfo":91,"targetDuration":10,"studyType":94,"phases":10,"briefSummary":95,"conditions":96,"keywords":10,"overallStatus":28,"whyStopped":10,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":109},{"fullName":5,"class":6},"Chiesi Farmaceutici S.p.A.","INDUSTRY",[8],{"label":9,"type":10,"description":10,"interventionNames":11},"Women with Fabry disease who were exposed to pegunigalsidase alfa during pregnancy and\u002For lactation",null,[12],"Other: Not applicable- observational study",[14],{"type":15,"name":16,"description":17,"armGroupLabels":18,"otherNames":10},"OTHER","Not applicable- observational study","Not applicable - observational study",[9],[20],{"name":21,"role":22,"phone":23,"phoneExt":10,"email":24},"Chiesi Clinical Trial","CONTACT","+3905212791","clinicaltrials_info@chiesi.com",[26,40,49,58,67],{"facility":27,"status":28,"city":29,"state":30,"zip":31,"country":32,"countryCode":33,"cosmosGeoPoint":34,"geoPoint":39,"contacts":10},"No physical study sites - Decentralized, web-based registry","RECRUITING","Washington D.C.","District of Columbia","20001","United States","US",{"type":35,"coordinates":36},"Point",[37,38],-77.03637,38.89511,{"lat":38,"lon":37},{"facility":27,"status":28,"city":41,"state":10,"zip":10,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":48,"contacts":10},"Berlin","Germany","DE",{"type":35,"coordinates":45},[46,47],13.41053,52.52437,{"lat":47,"lon":46},{"facility":27,"status":28,"city":50,"state":10,"zip":10,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":57,"contacts":10},"Rome","Italy","IT",{"type":35,"coordinates":54},[55,56],12.51133,41.89193,{"lat":56,"lon":55},{"facility":27,"status":28,"city":59,"state":10,"zip":10,"country":60,"countryCode":61,"cosmosGeoPoint":62,"geoPoint":66,"contacts":10},"Madrid","Spain","ES",{"type":35,"coordinates":63},[64,65],-3.70256,40.4165,{"lat":65,"lon":64},{"facility":27,"status":68,"city":69,"state":10,"zip":10,"country":70,"countryCode":71,"cosmosGeoPoint":72,"geoPoint":76,"contacts":10},"NOT_YET_RECRUITING","London","United Kingdom","UK",{"type":35,"coordinates":73},[74,75],-0.12574,51.50853,{"lat":75,"lon":74},{"type":78,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[80],{"name":81,"class":6},"ICON plc","100588409","maternal-and-postnatal-outcomes-study-mos-a-global-observational-registry-assessing-the-safety-of-elfabrio-in-women-with-fabry-disease-and-their-infants-during-pregnancy-and-breastfeeding-100588409",false,"NCT06941025","Maternal and Postnatal Outcomes Study (MOS): A Global Observational Registry Assessing the Safety of Elfabrio® in Women With Fabry Disease and Their Infants During Pregnancy and Breastfeeding","Maternal and Postnatal Outcomes Study (MOS) A Worldwide Decentralized Observational Registry to Evaluate the Safety in Women With Fabry Disease and Their Infants Exposed to Elfabrio® (Pegunigalsidase Alfa-iwxj\u002FPegunigalsidase Alfa) During Pregnancy and\u002For Lactation","MOS","Inclusion Criteria:\n\n* Female patients with Fabry disease who have been exposed to at least 1 dose of pegunigalsidase alfa at any time during pregnancy (defined as having received pegunigalsidase alfa within 30 days prior to the DOC and\u002For during pregnancy) and\u002For during lactation, and their infants.\n\n  o DOC, defined as 20\u002F7 gestational weeks, will be calculated from last menstrual period \\[LMP\\] or ultrasound\n* Patient or parent\u002Flegally authorized representative must be able to understand and provide consent through an Institutional Review Board \u002F Independent Ethics Committee (IRB\u002FIEC) approved Informed Consent Form.\n\nExclusion Criteria:\n\n* None","FEMALE",{"count":92,"type":93},10,"ESTIMATED","OBSERVATIONAL","The goal of this observational registry is to evaluate the safety and outcomes of pregnancy and lactation in women with Fabry disease who are exposed to pegunigalsidase alfa within 30 days prior to conception and\u002For during pregnancy and lactation.\n\nThe main objectives are to:\n\n* Assess pregnancy outcomes, including maternal and infant health.\n* Evaluate the occurrence of congenital malformations and other neonatal outcomes.\n\nThis is a global, decentralized, single-arm, prospective and retrospective registry planned to enroll participants over a 10-year period. Eligible patients may be enrolled by their physician or may self-enroll, where permitted by local regulations. Data will be collected through a secure web-based platform, allowing patients and physicians to enter information via electronic case report forms (eCRFs).\n\nPregnancy and clinical outcomes will be documented throughout pregnancy and up to 12 months post-birth. Data from self-enrolled patients will be confirmed by their primary care or attending physician. This registry is observational and does not impact clinical care or treatment decisions.",[97,98,99],"Fabry Disease","Pregnancy","Pregnancy Complications","2026-03-17",{"date":102,"type":103},"2026-03-19","ACTUAL",{"date":105,"type":103},"2025-05-23",{"date":107,"type":93},"2034-12",{"name":5,"class":6},5]