[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100457282":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":10,"centralContacts":22,"locations":28,"responsibleParty":142,"collaborators":10,"id":144,"slug":145,"hasResults":146,"nctId":147,"briefTitle":148,"officialTitle":149,"acronym":10,"eligibilityCriteria":150,"healthyVolunteers":146,"sex":151,"minAge":10,"maxAge":10,"enrollmentInfo":152,"targetDuration":10,"studyType":155,"phases":10,"briefSummary":156,"conditions":157,"keywords":159,"overallStatus":31,"whyStopped":10,"lastUpdateSubmitDate":163,"lastUpdatePostDateStruct":164,"startDateStruct":167,"completionDateStruct":169,"leadSponsor":171,"locationsCount":172},{"fullName":5,"class":6},"Alexion Pharmaceuticals, Inc.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Participants with Pediatric-onset HPP",null,"Each participant will be followed for a minimum of 5 years or, if applicable, until early withdrawal. Biochemical, clinical, imaging (if clinically indicated), and functional\u002Fquality of life outcomes relevant to HPP will be assessed.",[13],"Biological: Asfotase Alfa",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"BIOLOGICAL","Asfotase Alfa","All participants will receive asfotase alfa subcutaneously per standard of care. Unless otherwise specified per the Physician's standard of care, participants aged \\\u003C 2 years are recommended for a clinic visit approximately every 3 months after Enrollment until 2 years of age, after which they should have a clinic visit approximately every 6 months. Participants should be followed for 5 years, as possible.",[9],[21],"Strensiq",[23],{"name":24,"role":25,"phone":26,"phoneExt":10,"email":27},"Alexion Pharmaceuticals, Inc. (Sponsor)","CONTACT","1-855-752-2356","clinicaltrials@alexion.com",[29,43,52,61,70,79,89,97,106,115,124,133],{"facility":30,"status":31,"city":32,"state":33,"zip":34,"country":35,"countryCode":36,"cosmosGeoPoint":37,"geoPoint":42,"contacts":10},"Clinical Trial Site","RECRUITING","Hartford","Connecticut","06106","United States","US",{"type":38,"coordinates":39},"Point",[40,41],-72.68509,41.76371,{"lat":41,"lon":40},{"facility":30,"status":31,"city":44,"state":45,"zip":46,"country":35,"countryCode":36,"cosmosGeoPoint":47,"geoPoint":51,"contacts":10},"Chicago","Illinois","60611",{"type":38,"coordinates":48},[49,50],-87.65005,41.85003,{"lat":50,"lon":49},{"facility":30,"status":31,"city":53,"state":54,"zip":55,"country":35,"countryCode":36,"cosmosGeoPoint":56,"geoPoint":60,"contacts":10},"Boston","Massachusetts","02122",{"type":38,"coordinates":57},[58,59],-71.05977,42.35843,{"lat":59,"lon":58},{"facility":30,"status":31,"city":62,"state":63,"zip":64,"country":35,"countryCode":36,"cosmosGeoPoint":65,"geoPoint":69,"contacts":10},"Kansas City","Missouri","64108",{"type":38,"coordinates":66},[67,68],-94.57857,39.09973,{"lat":68,"lon":67},{"facility":30,"status":31,"city":71,"state":72,"zip":73,"country":35,"countryCode":36,"cosmosGeoPoint":74,"geoPoint":78,"contacts":10},"Mineola","New York","11501",{"type":38,"coordinates":75},[76,77],-73.64068,40.74927,{"lat":77,"lon":76},{"facility":30,"status":80,"city":81,"state":82,"zip":83,"country":35,"countryCode":36,"cosmosGeoPoint":84,"geoPoint":88,"contacts":10},"NOT_YET_RECRUITING","Cincinnati","Ohio","45229",{"type":38,"coordinates":85},[86,87],-84.51439,39.12711,{"lat":87,"lon":86},{"facility":30,"status":31,"city":90,"state":82,"zip":91,"country":35,"countryCode":36,"cosmosGeoPoint":92,"geoPoint":96,"contacts":10},"Columbus","43203",{"type":38,"coordinates":93},[94,95],-82.99879,39.96118,{"lat":95,"lon":94},{"facility":30,"status":80,"city":98,"state":99,"zip":100,"country":35,"countryCode":36,"cosmosGeoPoint":101,"geoPoint":105,"contacts":10},"Pittsburgh","Pennsylvania","15224",{"type":38,"coordinates":102},[103,104],-79.99589,40.44062,{"lat":104,"lon":103},{"facility":30,"status":31,"city":107,"state":108,"zip":109,"country":35,"countryCode":36,"cosmosGeoPoint":110,"geoPoint":114,"contacts":10},"Nashville","Tennessee","37112",{"type":38,"coordinates":111},[112,113],-86.78444,36.16589,{"lat":113,"lon":112},{"facility":30,"status":31,"city":116,"state":117,"zip":118,"country":35,"countryCode":36,"cosmosGeoPoint":119,"geoPoint":123,"contacts":10},"Salt Lake City","Utah","84108",{"type":38,"coordinates":120},[121,122],-111.89105,40.76078,{"lat":122,"lon":121},{"facility":30,"status":31,"city":125,"state":126,"zip":127,"country":35,"countryCode":36,"cosmosGeoPoint":128,"geoPoint":132,"contacts":10},"Charlottesville","Virginia","22903",{"type":38,"coordinates":129},[130,131],-78.47668,38.02931,{"lat":131,"lon":130},{"facility":30,"status":31,"city":134,"state":135,"zip":136,"country":35,"countryCode":36,"cosmosGeoPoint":137,"geoPoint":141,"contacts":10},"Madison","Wisconsin","53792",{"type":38,"coordinates":138},[139,140],-89.40123,43.07305,{"lat":140,"lon":139},{"type":143,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100457282","a-prospective-sub-study-of-the-global-hypophosphatasia-registry-100457282",false,"NCT05234567","A Prospective Sub-Study of the Global Hypophosphatasia Registry","A Prospective Observational Sub-Study of the Global Hypophosphatasia Registry to Describe the Potential Risk of Immune-Mediated Loss of Pharmacological Effect of Asfotase Alfa in Participants With Hypophosphatasia","Inclusion Criteria:\n\n* Any age or sex with a confirmed diagnosis of pediatric-onset HPP (that is, first HPP sign or symptom presented at \\\u003C 18 years of age).\n* Currently receiving asfotase alfa treatment at Enrollment (not treatment-naïve) or the Physician has decided to resume (not treatment-naïve) or start (treatment-naïve) the participant's asfotase alfa treatment within 6 months after Enrollment.\n* Participant must have documented alkaline phosphatase (ALP) activity below the lower limit of normal for age and sex, and a documented ALPL gene mutation (Note: An exception is made for infants with clinical features of HPP plus low ALP who need to start asfotase alfa treatment right away, at the Physician's discretion, but do not yet have a genetic result. In this case, ALPL gene documentation is not required at the time of sub-study enrollment but should be documented within 6 months after Enrollment).\n* Participant or participant's parent\u002Flegally authorized representative is able to read and\u002For understand the informed consent and study questionnaires in the local language.\n* Participant or participant's parent\u002Flegally authorized representative must be willing and able to give signed informed consent for this sub-study, and the participant must be willing to give written informed assent, if appropriate and required by local regulations.\n\nExclusion Criteria:\n\n* Currently participating in an Alexion-sponsored interventional clinical study. Participants who have concluded participation in an Alexion-sponsored asfotase alfa clinical study are eligible to enroll in this sub-study.","ALL",{"count":153,"type":154},30,"ESTIMATED","OBSERVATIONAL","In this prospective observational sub-study, participants with pediatric-onset hypophosphatasia (HPP) (perinatal\u002Finfantile- or juvenile-onset) of any age will be followed for a minimum of 5 years at sites in the United States and potentially 1 or 2 other countries.",[158],"Hypophosphatasia",[160,161,162],"Pediatric Onset","HPP","Asfotase alfa","2026-02-05",{"date":165,"type":166},"2026-02-09","ACTUAL",{"date":168,"type":166},"2022-08-25",{"date":170,"type":154},"2028-07-18",{"name":5,"class":6},12]