[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100601352":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":27,"locations":33,"responsibleParty":48,"collaborators":10,"id":50,"slug":51,"hasResults":52,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":52,"sex":58,"minAge":59,"maxAge":10,"enrollmentInfo":60,"targetDuration":10,"studyType":63,"phases":10,"briefSummary":64,"conditions":65,"keywords":67,"overallStatus":73,"whyStopped":10,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":84},{"fullName":5,"class":6},"Chiesi Farmaceutici S.p.A.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Fabry patients",null,"Adult patients whit genetically confirmed diagnosis of Fabry disease being treated or planning to start treatment with Pegunigalsidase alfa according to clinical practice. Participants will be required to meet the inclusion and exclusion criteria and sign informed consent to be enrolled in the study.",[13],"Drug: pegunigalsidase alfa",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","pegunigalsidase alfa","Pegunigalsidase alfa is 2 mg\u002FmL concentrate for solution and is administered via intravenous infusion every two weeks.",[9],[21],"Elfabrio",[23],{"name":24,"affiliation":25,"role":26},"Antonio Pisani, MD","AOU Federico II, Dipartimento di Nefrologia, Napoli, Italy","PRINCIPAL_INVESTIGATOR",[28],{"name":29,"role":30,"phone":31,"phoneExt":10,"email":32},"Chiesi Clinical Trial info","CONTACT","+3905212791","clinicaltrials_info@chiesi.com",[34],{"facility":35,"status":10,"city":36,"state":10,"zip":10,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"AOU Federico II, Dipartimento di Nefrologia","Naples","Italy","IT",{"type":40,"coordinates":41},"Point",[42,43],14.26811,40.85216,{"lat":43,"lon":42},[46],{"name":24,"role":30,"phone":47,"phoneExt":10,"email":10},"+39 081 7464521",{"type":49,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100601352","observational-study-on-long-term-use-of-pegunigalsidase-alfa-in-fabry-patients-in-a-real-world-setting-100601352",false,"NCT07109375","Observational Study on Long-term Use of Pegunigalsidase Alfa in Fabry Patients in a Real-world Setting","Observational Prospective Cohort Study on Long-term Effective and Safe Use of Pegunigalsidase Alfa in Adult Fabry Patients Under \"Real-world\" Setting","PEGASO","Inclusion Criteria:\n\n1. Male and female adults (≥ 18 years).\n2. Patients with a clinical diagnosis of Fabry disease confirmed by α-Gal A assay and detection of mutation in α-Gal A gene.\n3. Patients either taking or planning to take pegunigalsidase alfa as treatment for Fabry disease. The treatment decision must be made independently from participation in this study.\n4. Written informed consent to participate in the study and for the processing of personal data.\n\nExclusion Criteria:\n\n1. History of hypersensitivity reaction to pegunigalsidase alfa.\n2. Presence of any medical, emotional, behavioural, or psychological condition that, in the judgment of the physician, could interfere with the ability to participate in the study.\n3. Female subjects who are pregnant or planning to become pregnant during the study.","ALL","18 Years",{"count":61,"type":62},75,"ESTIMATED","OBSERVATIONAL","PEGASO is an observational study designed to collect prospective data on the effectiveness and safety of pegunigalsidase alfa in adult patients with Fabry disease, being treated or planning to start treatment, under real-world setting.",[66],"Fabry Disease",[68,69,70,71,72],"Pegunigalsidase alfa","Fabry disease","Real-world","Alpha-galactosidase A","Lysosomal storage disorders","NOT_YET_RECRUITING","2026-02-23",{"date":76,"type":77},"2026-02-24","ACTUAL",{"date":79,"type":62},"2026-04",{"date":81,"type":62},"2028-12",{"name":83,"class":6},"Chiesi Italia",1]