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