[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"phenylketonuria-maternal\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:phenylketonuria-maternal":23},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":4,"briefSummary":21,"conditions":22,"keywords":24,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"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":18,"type":19},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.",[23],"Phenylketonuria, Maternal",[25,26,27,28,29,30],"Phase 4","Observational","Maternal","Pregnancy Outcomes","Exposure","Breastfeeding Outcomes","RECRUITING","2026-03-20",{"date":34,"type":35},"2026-03-24","ACTUAL",{"date":37,"type":35},"2022-11-22",{"date":39,"type":19},"2032-10-04",{"name":41,"class":42},"BioMarin Pharmaceutical","INDUSTRY",4]