[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100381857":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":10,"centralContacts":23,"locations":29,"responsibleParty":44,"collaborators":10,"id":46,"slug":47,"hasResults":48,"nctId":49,"briefTitle":50,"officialTitle":50,"acronym":10,"eligibilityCriteria":51,"healthyVolunteers":48,"sex":52,"minAge":10,"maxAge":10,"enrollmentInfo":53,"targetDuration":10,"studyType":56,"phases":10,"briefSummary":57,"conditions":58,"keywords":60,"overallStatus":32,"whyStopped":10,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":71},{"fullName":5,"class":6},"Amicus Therapeutics","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Cohort 1",null,"Cohort 1 will be pregnant and\u002For breastfeeding patients who have Fabry Disease, and have been exposed to at least 1 dose of migalastat during pregnancy and\u002For breastfeeding.",[13],"Drug: migalastat",{"label":15,"type":10,"description":16,"interventionNames":10},"Cohort 2","Cohort 2 will be pregnant and\u002For breastfeeding patients who have Fabry Disease, who were not exposed to migalastat during pregnancy and\u002For breastfeeding.",[18],{"type":19,"name":20,"description":21,"armGroupLabels":22,"otherNames":10},"DRUG","migalastat","This is an observational study. Patients as described in Cohort 1 should have been exposed to at least 1 dose of migalastat during pregnancy and\u002For breastfeeding.",[9],[24],{"name":25,"role":26,"phone":27,"phoneExt":10,"email":28},"Pregnancy Registry Call Center","CONTACT","888-239-0758","galafoldpregnancy@ubc.com",[30],{"facility":31,"status":32,"city":33,"state":34,"zip":35,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":10},"Amicus Therapeutics, Inc. Pregnancy Registry","RECRUITING","Philadelphia","Pennsylvania","19104","United States","US",{"type":39,"coordinates":40},"Point",[41,42],-75.16362,39.95238,{"lat":42,"lon":41},{"type":45,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100381857","a-global-prospective-observational-study-of-women-with-fabry-disease-and-their-infants-during-pregnancy-and-breastfeeding-100381857",false,"NCT04252066","A Global Prospective Observational Study of Women With Fabry Disease and Their Infants During Pregnancy and Breastfeeding","Inclusion Criteria:\n\nFemale patients meeting the following criteria will be eligible for study enrollment:\n\n1. Patients with Fabry disease who are pregnant and\u002For breastfeeding, whether or not they are exposed to migalastat\n2. Able and willing to provide informed consent or assent, if applicable.\n3. Able and willing to provide HCP contact information.\n\nExclusion Criteria:\n\nNone","FEMALE",{"count":54,"type":55},20,"ESTIMATED","OBSERVATIONAL","This is a global prospective observational study of women with Fabry disease and their infants during pregnancy and\u002For breastfeeding. The study will evaluate outcomes of pregnancy and\u002For breastfeeding in women and infants exposed to migalastat.",[59],"Fabry Disease",[20,59,61],"Women with Fabry Disease","2025-07-02",{"date":64,"type":65},"2025-07-08","ACTUAL",{"date":67,"type":65},"2025-03-18",{"date":69,"type":55},"2030-02",{"name":5,"class":6},1]