[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100495693":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":32,"centralContacts":36,"locations":43,"responsibleParty":58,"collaborators":10,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":10,"eligibilityCriteria":66,"healthyVolunteers":62,"sex":67,"minAge":10,"maxAge":10,"enrollmentInfo":68,"targetDuration":10,"studyType":71,"phases":10,"briefSummary":72,"conditions":73,"keywords":10,"overallStatus":46,"whyStopped":10,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},{"fullName":5,"class":6},"Sanofi","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Pregnant women exposed to avalglucosidase alfa",null,"Pregnant women with a confirmed diagnosis of Pompe disease and avalglucosidase alfa exposure during the pregnancy and\u002For lactation",[13],"Biological: avalglucosidase alfa-NGPT (GZ402666) IV",{"label":15,"type":10,"description":16,"interventionNames":17},"Infants born to mother\u002Ffather exposed to avalglucosidase alfa","Infants born to mother\u002Ffather with a confirmed diagnosis of Pompe disease and exposed to avalglucosidase alfa",[18],"Biological: avalglucosidase alfa-NGPT (GZ402666)",[20,27],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"BIOLOGICAL","avalglucosidase alfa-NGPT (GZ402666) IV","intravenous infusion",[9],[26],"NEXVIAZYME",{"type":21,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"avalglucosidase alfa-NGPT (GZ402666)","exposed via pregnancy and lactation",[15],[26],[33],{"name":34,"affiliation":5,"role":35},"Clinical Sciences & Operations","STUDY_DIRECTOR",[37],{"name":38,"role":39,"phone":40,"phoneExt":41,"email":42},"Trial Transparency email recommended (Toll free for US & Canada)","CONTACT","800-633-1610","option 6","Contact-US@sanofi.com",[44],{"facility":45,"status":46,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":10},"Investigational site worldwide","RECRUITING","Bridgewater","New Jersey","08807","United States","US",{"type":53,"coordinates":54},"Point",[55,56],-74.64815,40.60079,{"lat":56,"lon":55},{"type":59,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100495693","avalglucosidase-alfa-pregnancy-study-100495693",false,"NCT05734521","Avalglucosidase Alfa Pregnancy Study","A Descriptive Safety Study Based on Data Collected From Women and Their Offspring Exposed to Nexviazyme\u002FNexviadyme (Avalglucosidase Alfa-ngpt\u002FAvalglucosidase Alfa) During Pregnancy and\u002For Lactation in the Postmarketing Setting","Inclusion Criteria:\n\n* Women and their offspring exposed to avalglucosidase alfa during pregnancy and\u002For lactation for whom an Individual Case Safety Report (ICSR) has been submitted to the Sanofi Global Pharmacovigilance (PV) department, and\u002For,\n* Women exposed to avalglucosidase alfa during pregnancy and\u002For lactation who have provided informed consent to enroll in the Pompe Pregnancy Sub-registry.\n\nExclusion Criteria:\n\nThere are no exclusion criteria in this study.\n\nThe above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.","FEMALE",{"count":69,"type":70},100,"ESTIMATED","OBSERVATIONAL","This is a worldwide, descriptive safety study collecting data on women and their offspring exposed to avalglucosidase alfa during pregnancy and\u002For lactation, to assess the risks of avalglucsodiase alfa on pregnancy and maternal complications and adverse effects in the developing fetus, neonate, and infant.\n\n* Outcomes in exposed infants, including growth and development, will be assessed through at least the first year of life.\n* Data will be collected for approximately 10 years.",[74,75],"Pompe Disease","Pregnancy","2026-01-14",{"date":78,"type":79},"2026-01-16","ACTUAL",{"date":81,"type":79},"2022-10-26",{"date":83,"type":70},"2032-10-31",{"name":5,"class":6},1]