[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100424354":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":26,"centralContacts":31,"locations":40,"responsibleParty":55,"collaborators":10,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":10,"eligibilityCriteria":63,"healthyVolunteers":59,"sex":64,"minAge":10,"maxAge":10,"enrollmentInfo":65,"targetDuration":68,"studyType":69,"phases":10,"briefSummary":70,"conditions":71,"keywords":10,"overallStatus":74,"whyStopped":10,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":84},{"fullName":5,"class":6},"JW Pharmaceutical","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Hemophilia A with FVIII inhibitors",null,"Hemophilia A patients with FVIII inhibitors will administer Emicizumab at a loading dose of 3 mg\u002Fkg\u002Fweek SC for the first 4 weeks of treatment followed by 1.5 mg\u002Fkg QW SC or 3mg\u002Fkg Q2W or 6mg\u002Fkg Q4W",[13],"Drug: Emicizumab subcutaneous injection",{"label":15,"type":10,"description":16,"interventionNames":17},"Hemophilia A without FVIII inhibitors","Hemophilia A patients without FVIII inhibitors will administer Emicizumab at a loading dose of 3 mg\u002Fkg\u002Fweek SC for the first 4 weeks of treatment followed by 1.5 mg\u002Fkg QW SC or 3mg\u002Fkg Q2W or 6mg\u002Fkg Q4W",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DRUG","Emicizumab subcutaneous injection","Safety and efficacy and PK, FVIII inhibitor titers will be evaluated by follow-up observation.",[9,15],[25],"Emicizumab concentration, FVIII inhibitor titer, FVIII Activity lab test",[27],{"name":28,"affiliation":29,"role":30},"Chuhl Joo Lyu, Prof","Severance Hospital","PRINCIPAL_INVESTIGATOR",[32,36],{"name":28,"role":33,"phone":34,"phoneExt":10,"email":35},"CONTACT","+82222282060","CJ@yuhs.ac",{"name":37,"role":33,"phone":38,"phoneExt":10,"email":39},"YoungShil Park, Prof.","+8224407174","pysmd@khnmc.or.kr",[41],{"facility":42,"status":43,"city":44,"state":10,"zip":10,"country":45,"countryCode":10,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"Yonsei University Severance Hospital","RECRUITING","Seoul","South Korea",{"type":47,"coordinates":48},"Point",[49,50],126.9784,37.566,{"lat":50,"lon":49},[53],{"name":54,"role":33,"phone":34,"phoneExt":10,"email":35},"Chuhl-Joo Lyu, Prof",{"type":56,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100424354","the-safety-of-emicizumab-sc-injection-in-korean-hemophilia-a-patients-withwithout-fviii-inhibitors-100424354",false,"NCT04805801","The Safety of Emicizumab SC Injection in Korean Hemophilia A Patients With\u002FWithout FVIII Inhibitors","Observational Study on the Safety of Hemlibra Subcutaneous Injection in Korean Hemophilia A Patients With\u002FWithout FVIII Inhibitors","Inclusion Criteria:\n\n1. Patients with Hemophilia A (congenital factor VIII deficiency) who will receive Hemlibra SC inj. according to medical decision by investigator\n2. Signed informed consent form\n\nExclusion Criteria:\n\n1. Subjects who are hypersensitive to Emicizumab\n2. Subjects who are hypersensitive to mouse or hamster protein\n3. Subjects with myocardial infarction or the history who are prohibited from administering L-Arginine containing drug\n4. Subjects who participated in other clinical trials within a month before enrollment (or the first administration of Hemlibra SC inj.) (Unable to participate in other clinical trials related to Hemophilia A treatment even after enrollment)\n5. Subjects who the investigator deems inappropriate for the study.\n6. Moderate\u002FMild for Hemophilia A patients without FVIII inhibitors","ALL",{"count":66,"type":67},17,"ESTIMATED","6 Months","OBSERVATIONAL","To evaluate Safety and efficacy and pharmacokinetics, FVIII Inhibitor titers of Hemlibra subcutaneous injection (SC inj.) in Korean Hemophilia A patients with\u002Fwithout FVIII Inhibitors.",[72,73],"Hemophilia A With Inhibitor","Hemophilia A Without Inhibitor","UNKNOWN","2021-07-15",{"date":77,"type":78},"2021-07-21","ACTUAL",{"date":80,"type":78},"2019-08-28",{"date":82,"type":67},"2025-02",{"name":5,"class":6},1]