[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100483785":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":24,"locations":30,"responsibleParty":96,"collaborators":98,"id":101,"slug":102,"hasResults":103,"nctId":104,"briefTitle":105,"officialTitle":105,"acronym":106,"eligibilityCriteria":107,"healthyVolunteers":103,"sex":108,"minAge":10,"maxAge":10,"enrollmentInfo":109,"targetDuration":10,"studyType":112,"phases":10,"briefSummary":113,"conditions":114,"keywords":116,"overallStatus":33,"whyStopped":10,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":132},{"fullName":5,"class":6},"BioMarin Pharmaceutical","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Pregnant Women with PKU",null,"This study will enroll pregnant women diagnosed with PKU who have been treated with pegvaliase from 2 weeks prior to LMP or at any time during pregnancy.",[13],"Drug: Pegvaliase",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"DRUG","Pegvaliase","Pregnant women exposed to pegvaliase within 2 weeks prior to LMP.",[9],[21],{"name":22,"affiliation":5,"role":23},"Medical Director, MD","STUDY_DIRECTOR",[25],{"name":26,"role":27,"phone":28,"phoneExt":10,"email":29},"165-504 Program Director","CONTACT","1-800-983-4587","medinfo@bmrn.com",[31,50,66,81],{"facility":32,"status":33,"city":34,"state":35,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"Syneos Health","RECRUITING","Wilmington","North Carolina","28403","United States","US",{"type":40,"coordinates":41},"Point",[42,43],-77.94604,34.23556,{"lat":43,"lon":42},[46],{"name":47,"role":27,"phone":48,"phoneExt":10,"email":49},"Coordinating Center","833-672-2203","PalynziqPregnancyStudy@syneoshealth.com",{"facility":51,"status":33,"city":52,"state":10,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":60,"contacts":61},"Metabolics and Genetics in Calgary (MAGIC)","Calgary","T2E 7Z4","Canada","CA",{"type":40,"coordinates":57},[58,59],-114.08529,51.05011,{"lat":59,"lon":58},[62],{"name":63,"role":27,"phone":64,"phoneExt":10,"email":65},"Aneal Khan, Dr","587-885-3158","aneal.khan@discoverydna.ca",{"facility":67,"status":33,"city":68,"state":10,"zip":69,"country":70,"countryCode":71,"cosmosGeoPoint":72,"geoPoint":76,"contacts":77},"Universitaetsklinikum Hamburg Eppendorf","Hamburg","20246","Germany","DE",{"type":40,"coordinates":73},[74,75],9.99302,53.55073,{"lat":75,"lon":74},[78],{"name":79,"role":27,"phone":10,"phoneExt":10,"email":80},"Professor Muntau","muntau@uke.de",{"facility":82,"status":33,"city":83,"state":10,"zip":84,"country":85,"countryCode":86,"cosmosGeoPoint":87,"geoPoint":91,"contacts":92},"Ospedale San Paolo","Milan","20142","Italy","IT",{"type":40,"coordinates":88},[89,90],12.59836,42.78235,{"lat":90,"lon":89},[93],{"name":94,"role":27,"phone":10,"phoneExt":10,"email":95},"Dr. Rovelli","valentina.rovelli@asst-santipaolocarlo.it",{"type":97,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[99],{"name":32,"class":100},"OTHER","100483785","a-global-multicenter-study-to-assess-maternal-fetal-and-infant-outcomes-of-exposure-to-palynziq-pegvaliase-during-pregnancy-and-breastfeeding-100483785",false,"NCT05579548","A Global, Multicenter Study to Assess Maternal, Fetal and Infant Outcomes of Exposure to Palynziq® (Pegvaliase) During Pregnancy and Breastfeeding","PALomino","Inclusion Criteria:\n\n* Subject (or a legally authorized representative) consent obtained prior to enrollment. Consent will be obtained in compliance with any country-specific regulations or requirements\n* Confirmation of ongoing pregnancy. Subjects with unknown outcomes will be classified as prospective pregnancies; subjects who have undergone prenatal testing (eg, targeted ultrasound, amniocentesis) regardless of findings will be classified as retrospective pregnancies\n* Diagnosed with PKU per local standard of care\n* Documentation that the subject was treated with pegvaliase at any point starting from 2 weeks prior to the date of LMP\n* Agrees to permit the Investigator (ie, CRP, CCA, PI) to contact the subject's HCPs (eg, PCP, PKU-treating physician, OB, nurse, midwife) and the infant's HCP (eg, pediatrician, neonatologist) for medical information\n\nExclusion Criteria:\n\n• Currently participating in a BioMarin sponsored interventional study of any investigational product, device, or procedure","FEMALE",{"count":110,"type":111},50,"ESTIMATED","OBSERVATIONAL","This is a Phase 4 observational study designed to assess the impact of Palynziq ® (pegvaliase) treatment in pregnant women with PKU and on their offspring who were exposed to pegvaliase at any time during pregnancy and breastfeeding.",[115],"Phenylketonuria, Maternal",[117,118,119,120,121,122],"Phase 4","Observational","Maternal","Pregnancy Outcomes","Exposure","Breastfeeding Outcomes","2026-03-20",{"date":125,"type":126},"2026-03-24","ACTUAL",{"date":128,"type":126},"2022-11-22",{"date":130,"type":111},"2032-10-04",{"name":5,"class":6},4]