[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100559511":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":10,"centralContacts":19,"locations":27,"responsibleParty":40,"collaborators":10,"id":42,"slug":43,"hasResults":44,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":10,"eligibilityCriteria":48,"healthyVolunteers":44,"sex":49,"minAge":10,"maxAge":10,"enrollmentInfo":50,"targetDuration":10,"studyType":53,"phases":10,"briefSummary":54,"conditions":55,"keywords":57,"overallStatus":30,"whyStopped":10,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":68},{"fullName":5,"class":6},"Takeda","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Immune Globulin Subcutaneous (Human), 20% Solution",null,"Participants with primary immunodeficiency disease who received Immune Globulin Subcutaneous (Human) 20% infusion in accordance with package insert.",[13],"Drug: Immune Globulin Subcutaneous (Human), 20% Solution",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":10},"DRUG","CUVITRU 20% Solution",[9],[20,25],{"name":21,"role":22,"phone":23,"phoneExt":10,"email":24},"Takeda Contact","CONTACT","+1-877-825-3327","medinfoUS@takeda.com",{"name":26,"role":22,"phone":10,"phoneExt":10,"email":10},"Study Director",[28],{"facility":29,"status":30,"city":31,"state":31,"zip":10,"country":32,"countryCode":33,"cosmosGeoPoint":34,"geoPoint":39,"contacts":10},"Takeda selected site","RECRUITING","Tokyo","Japan","JP",{"type":35,"coordinates":36},"Point",[37,38],139.69171,35.6895,{"lat":38,"lon":37},{"type":41,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100559511","a-database-survey-to-evaluate-the-safety-of-immune-globulin-subcutaneous-human-20-solution-in-participants-with-primary-immunodeficiency-100559511",false,"NCT06565078","A Database Survey to Evaluate the Safety of Immune Globulin Subcutaneous (Human), 20% Solution in Participants With Primary Immunodeficiency","Post-marketing Database Survey: A Cohort Study to Evaluate the Safety of Cuvitru in Patients With Primary Immunodeficiency Using the PIDJ2 (Primary Immunodeficiency Database in Japan) Registry","Inclusion Criteria:\n\n1. Patients with primary immunodeficiency (PID) enrolled in the PID patient registry.\n2. Participant for whom study drug is entered in the therapeutic drug field on the data set.\n3. Participant who is entered the intractable disease diagnosis corresponding to PID in the intractable disease information field.\n4. Participant for whom the presence or absence of adverse events has been entered in the column of adverse events.\n\nExclusion Criteria:\n\n1. Participant for whom study drug has not been entered in the drug name in the medical history field during the period from January 24, 2024 to January 23, 2029.\n2. Participant who is not entered the intractable disease diagnosis corresponding to PID in the intractable disease information field.\n3. Participant for whom the presence or absence of adverse events has not been entered in the column of adverse events.","ALL",{"count":51,"type":52},100,"ESTIMATED","OBSERVATIONAL","This study is a retrospective database study in Japan to evaluate the safety of Immune Globulin Subcutaneous (Human), 20% Solution in participants with primary immunodeficiency disease (PID). This survey will conduct in use of medical database called PIDJ2.",[56],"Primary Immunodeficiency Diseases (PID)",[58],"Primary immunodeficiency disease","2026-02-18",{"date":61,"type":62},"2026-02-20","ACTUAL",{"date":64,"type":62},"2025-02-17",{"date":66,"type":52},"2030-07-31",{"name":5,"class":6},1]