[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100653932":3},{"organization":4,"outcomesModule":7,"designInfo":14,"detailedDescription":17,"studyPopulation":18,"armGroups":19,"interventions":24,"overallOfficials":13,"centralContacts":33,"locations":40,"responsibleParty":130,"collaborators":13,"id":132,"slug":133,"hasResults":134,"nctId":135,"briefTitle":136,"officialTitle":137,"acronym":13,"eligibilityCriteria":138,"healthyVolunteers":134,"sex":139,"minAge":140,"maxAge":13,"enrollmentInfo":141,"targetDuration":13,"studyType":144,"phases":13,"briefSummary":145,"conditions":146,"keywords":149,"overallStatus":153,"whyStopped":13,"lastUpdateSubmitDate":154,"lastUpdatePostDateStruct":155,"startDateStruct":158,"completionDateStruct":160,"leadSponsor":162,"locationsCount":163},{"fullName":5,"class":6},"AryoGen Pharmed Co.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":13},[9],{"measure":10,"description":11,"timeFrame":12},"Evaluation of the immunogenicity profile of the Coageight (rFVIII-Fc, manufactured by AryoGen Pharmed Co.)","Assessing the prevalence of inhibitors against factor VIII in the study population, as measured by a positive Bethesda test","Day 0 (-7 to 0 days)",null,{"allocation":13,"interventionModel":13,"interventionModelDescription":13,"primaryPurpose":13,"observationalModel":15,"timePerspective":16,"maskingInfo":13},"COHORT","CROSS_SECTIONAL","This is a cross-sectional, observational, multi-center study to assess the prevalence of inhibitor development in hemophilia A patients receiving Coageight (rFVIII-Fc, AryoGen Pharmed Co.). To gather the data during the predefined visit of the study, a booklet will be filled by the designated physician. The primary objective of this study is to evaluate the immunogenicity profile of Coageight by assessing the prevalence of factor VIII inhibitors in the study population, as determined by a positive Bethesda assay. The sample size of the study is set at 262 patients.","A total of 262 Iranian patients diagnosed with hemophilia A and treated with Coageight® (rFVIII-Fc fused, AryoGen Pharmed Co.)",[20],{"label":21,"type":13,"description":13,"interventionNames":22},"Patients receiving Coageight (rFVIII-Fc, AryoGen Pharmed Co.)",[23],"Drug: efmoroctocog alfa",[25],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"DRUG","efmoroctocog alfa","This study assesses patients with a history of at least 10 exposure days (EDs) to recombinant factor VIII with Fc fusion (Coageight) within the 12 months prior to enrollment.",[21],[31,32],"Recombinant Factor VIII with Fc Fusion","Coageight",[34],{"name":35,"role":36,"phone":37,"phoneExt":38,"email":39},"Hamidreza Kafi, Clinical Pharmecy Ph.D","CONTACT","00982143473000","141","Kafi.H@Orchidpharmed.com",[41,59,73,87,104,119],{"facility":42,"status":13,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Shahid Baqaei 2 Hospital","Ahvāz","Ahvaz","6138933333","Iran","IR",{"type":49,"coordinates":50},"Point",[51,52],48.6842,31.31901,{"lat":52,"lon":51},[55],{"name":56,"role":36,"phone":57,"phoneExt":13,"email":58},"Bijan Keykhai","0098 61 3375 0000","baqaei.hospital@ajums.ac.ir",{"facility":60,"status":13,"city":61,"state":61,"zip":62,"country":46,"countryCode":47,"cosmosGeoPoint":63,"geoPoint":67,"contacts":68},"Seyyed al-Shohada Hospital","Isfahan","8184917354",{"type":49,"coordinates":64},[65,66],51.67462,32.65246,{"lat":66,"lon":65},[69],{"name":70,"role":36,"phone":71,"phoneExt":13,"email":72},"Majid Qanavat","0098 31 3235 0210","omid@mui.ac.ir",{"facility":74,"status":13,"city":75,"state":75,"zip":76,"country":46,"countryCode":47,"cosmosGeoPoint":77,"geoPoint":81,"contacts":82},"Soroor Clinic","Mashhad","9139963185",{"type":49,"coordinates":78},[79,80],59.60567,36.29807,{"lat":80,"lon":79},[83],{"name":84,"role":36,"phone":85,"phoneExt":13,"email":86},"Zahra Badiei","0098 51 3364 5013","Sheikh.hos@mums.ac.ir",{"facility":88,"status":13,"city":89,"state":89,"zip":90,"country":46,"countryCode":47,"cosmosGeoPoint":91,"geoPoint":95,"contacts":96},"Shahid Ayatollah Dastgheib Hospital","Shiraz","7145683769",{"type":49,"coordinates":92},[93,94],52.53113,29.61031,{"lat":94,"lon":93},[97,101],{"name":98,"role":36,"phone":99,"phoneExt":13,"email":100},"Mohammadreza Bordbar","0098 71 3228 9308","bordbarm@sums.ac.ir",{"name":102,"role":103,"phone":13,"phoneExt":13,"email":13},"Asghar Bazrafshan","SUB_INVESTIGATOR",{"facility":105,"status":13,"city":106,"state":107,"zip":108,"country":46,"countryCode":47,"cosmosGeoPoint":109,"geoPoint":113,"contacts":114},"Imam Khomeini Hospital","Tehran","Tehran Province","1419733141",{"type":49,"coordinates":110},[111,112],51.42151,35.69439,{"lat":112,"lon":111},[115],{"name":116,"role":36,"phone":117,"phoneExt":13,"email":118},"Mohammadreza Shaverdi","009821 6119 0000","Imamhospital@tums.ac.ir",{"facility":120,"status":13,"city":106,"state":107,"zip":121,"country":46,"countryCode":47,"cosmosGeoPoint":122,"geoPoint":124,"contacts":125},"Mofid Children's Hospital","1551415468",{"type":49,"coordinates":123},[111,112],{"lat":112,"lon":111},[126],{"name":127,"role":36,"phone":128,"phoneExt":13,"email":129},"Samin Alavi Bojestani","0098 21 2222 7021","info-mch@sbmu.ac.ir",{"type":131,"investigatorFullName":13,"investigatorTitle":13,"investigatorAffiliation":13,"oldNameTitle":13,"oldOrganization":13},"SPONSOR","100653932","prevalence-of-inhibitor-development-in-hemophilia-a-patients-receiving-coageight-a-multicenter-cross-sectional-observational-study-100653932",false,"NCT07791836","Prevalence of Inhibitor Development in Hemophilia A Patients Receiving Coageight: A Multicenter Cross-sectional Observational Study","A Cross-sectional, Observational, Multi-center Study to Assess the Prevalence of Inhibitor Development in Hemophilia A Patients Receiving Coageight (rFVIII-Fc, Manufactured by AryoGen Pharmed Co.)","Inclusion Criteria:\n\n1. Male patients aged 2 years or older with a signed informed consent by them or their legal guardian\n2. Hemophilia A patients with ≥ 50 exposure days to any FVIII product, based on the patient's medical record and the physician's opinion\n3. History of receiving at least 10 exposure days with Coageight during the past 12 months, based on the patient's medical records and the physician's opinion\n\nExclusion Criteria:\n\n1. History of any other coagulation disorders except hemophilia A and disorders related to immune system deficiencies (except for the patients who have undergone Immune Tolerance Induction (ITI) treatment due to inhibitor formation)\n2. Patients with hepatitis B or C (based on the patient's medical records), due to potential interference with the inhibitor assessments\n3. Participation or intent to participate in another research study during this study period\n4. Inability or unwillingness of the patient to meet the protocol requirements, as determined by the physician (e.g., physical or psychological issues)","MALE","2 Years",{"count":142,"type":143},262,"ESTIMATED","OBSERVATIONAL","This is a cross-sectional, observational, multi-center study to assess the prevalence of inhibitor development in hemophilia A patients receiving Coageight (rFVIII-Fc, AryoGen Pharmed Co.).",[147,148],"Hemophilia A","Hemophilia",[150,32,151,152,31,147],"Factor VIII","Prevalence","Immunogenicity","NOT_YET_RECRUITING","2026-08-27",{"date":156,"type":157},"2026-08-28","ACTUAL",{"date":159,"type":143},"2026-08-23",{"date":161,"type":143},"2027-02-20",{"name":5,"class":6},6]