[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100245706":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":32,"centralContacts":10,"locations":36,"responsibleParty":384,"collaborators":10,"id":386,"slug":387,"hasResults":388,"nctId":389,"briefTitle":390,"officialTitle":391,"acronym":10,"eligibilityCriteria":392,"healthyVolunteers":388,"sex":393,"minAge":10,"maxAge":10,"enrollmentInfo":394,"targetDuration":10,"studyType":397,"phases":10,"briefSummary":398,"conditions":399,"keywords":10,"overallStatus":401,"whyStopped":10,"lastUpdateSubmitDate":402,"lastUpdatePostDateStruct":403,"startDateStruct":405,"completionDateStruct":407,"leadSponsor":409,"locationsCount":410},{"fullName":5,"class":6},"Hoffmann-La Roche","INDUSTRY",[8,14,17],{"label":9,"type":10,"description":11,"interventionNames":12},"Cohort A: Adults and Adolescents with FVIII Inhibitors",null,"Adults and adolescents with hemophilia A of any severity with the presence of FVIII inhibitors will be observed.",[13],"Drug: Bypassing Agents",{"label":15,"type":10,"description":16,"interventionNames":10},"Cohort B: Children with FVIII Inhibitors","Children with hemophilia A of any severity with the presence of FVIII inhibitors will be observed.",{"label":18,"type":10,"description":19,"interventionNames":20},"Cohort C: Adults and Adolescents without FVIII Inhibitors","Adults and adolescents with severe hemophilia A without the presence of FVIII inhibitors will be observed.",[21],"Drug: FVIII Replacement",[23,28],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":10},"DRUG","Bypassing Agents","Episodic or prophylactic treatment with the use of bypassing agents must be documented for at least the last 6 months prior to the study. During the study, treatment for bleeds will be documented. The choice of coagulation product is at the discretion of the investigator according to local practice standards in this non-interventional study and there are no specific protocol-defined interventions.",[9],{"type":24,"name":29,"description":30,"armGroupLabels":31,"otherNames":10},"FVIII Replacement","Episodic or prophylactic treatment with the use of FVIII replacement must be documented for at least the last 6 months prior to the study. During the study, treatment for bleeds will be documented. The choice of coagulation product is at the discretion of the investigator according to local practice standards in this non-interventional study and there are no specific protocol-defined interventions.",[18],[33],{"name":34,"affiliation":5,"role":35},"Clinical Trials","STUDY_DIRECTOR",[37,50,60,70,80,90,100,109,119,129,139,151,161,172,181,190,201,212,224,234,245,254,263,267,276,285,296,305,314,323,334,344,355,364,373],{"facility":38,"status":10,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":10},"Santa Monica Oncology Center","Santa Monica","California","90403","United States","US",{"type":45,"coordinates":46},"Point",[47,48],-118.49138,34.01949,{"lat":48,"lon":47},{"facility":51,"status":10,"city":52,"state":53,"zip":54,"country":42,"countryCode":43,"cosmosGeoPoint":55,"geoPoint":59,"contacts":10},"University of Colorado Denver, Children's Hospital","Aurora","Colorado","80045",{"type":45,"coordinates":56},[57,58],-104.83192,39.72943,{"lat":58,"lon":57},{"facility":61,"status":10,"city":62,"state":63,"zip":64,"country":42,"countryCode":43,"cosmosGeoPoint":65,"geoPoint":69,"contacts":10},"Georgetown Uni Medical Center; Lombardi Cancer Center","Washington D.C.","District of Columbia","20007",{"type":45,"coordinates":66},[67,68],-77.03637,38.89511,{"lat":68,"lon":67},{"facility":71,"status":10,"city":72,"state":73,"zip":74,"country":42,"countryCode":43,"cosmosGeoPoint":75,"geoPoint":79,"contacts":10},"Winship Cancer Institute","Atlanta","Georgia","30322",{"type":45,"coordinates":76},[77,78],-84.38798,33.749,{"lat":78,"lon":77},{"facility":81,"status":10,"city":82,"state":83,"zip":84,"country":42,"countryCode":43,"cosmosGeoPoint":85,"geoPoint":89,"contacts":10},"Tulane Uni Health Sciences Center","New Orleans","Louisiana","70112-2699",{"type":45,"coordinates":86},[87,88],-90.07507,29.95465,{"lat":88,"lon":87},{"facility":91,"status":10,"city":92,"state":93,"zip":94,"country":42,"countryCode":43,"cosmosGeoPoint":95,"geoPoint":99,"contacts":10},"Children's Hospital of Michigan; Pediatrics","Detroit","Michigan","48201",{"type":45,"coordinates":96},[97,98],-83.04575,42.33143,{"lat":98,"lon":97},{"facility":101,"status":10,"city":102,"state":102,"zip":103,"country":42,"countryCode":43,"cosmosGeoPoint":104,"geoPoint":108,"contacts":10},"Cornell Univ Medical College; Hematology-Oncolog","New York","10021",{"type":45,"coordinates":105},[106,107],-74.00597,40.71427,{"lat":107,"lon":106},{"facility":110,"status":10,"city":111,"state":112,"zip":113,"country":42,"countryCode":43,"cosmosGeoPoint":114,"geoPoint":118,"contacts":10},"Oregon Health & Science Uni ; Dept of Pediatrics","Portland","Oregon","97201",{"type":45,"coordinates":115},[116,117],-122.67621,45.52345,{"lat":117,"lon":116},{"facility":120,"status":10,"city":121,"state":122,"zip":123,"country":42,"countryCode":43,"cosmosGeoPoint":124,"geoPoint":128,"contacts":10},"University of Pittsburgh","Pittsburgh","Pennsylvania","15213",{"type":45,"coordinates":125},[126,127],-79.99589,40.44062,{"lat":127,"lon":126},{"facility":130,"status":10,"city":131,"state":132,"zip":133,"country":42,"countryCode":43,"cosmosGeoPoint":134,"geoPoint":138,"contacts":10},"Bloodworks Northwest (formerly Puget Sound Blood Center); Hemophilia","Seattle","Washington","98104",{"type":45,"coordinates":135},[136,137],-122.33207,47.60621,{"lat":137,"lon":136},{"facility":140,"status":10,"city":141,"state":142,"zip":143,"country":144,"countryCode":145,"cosmosGeoPoint":146,"geoPoint":150,"contacts":10},"Royal Prince Alfred Hospital; Haematology","Camperdown","New South Wales","2050","Australia","AU",{"type":45,"coordinates":147},[148,149],151.17642,-33.88965,{"lat":149,"lon":148},{"facility":152,"status":10,"city":153,"state":154,"zip":155,"country":144,"countryCode":145,"cosmosGeoPoint":156,"geoPoint":160,"contacts":10},"The Alfred Hospital, Melbourne; Thrombosis and Haemostasis Unit","Melbourne","Victoria","3004",{"type":45,"coordinates":157},[158,159],144.96332,-37.814,{"lat":159,"lon":158},{"facility":162,"status":10,"city":163,"state":10,"zip":164,"country":165,"countryCode":166,"cosmosGeoPoint":167,"geoPoint":171,"contacts":10},"Peking Union Medical College Hospital","Beijing","100730","China","CN",{"type":45,"coordinates":168},[169,170],116.39723,39.9075,{"lat":170,"lon":169},{"facility":173,"status":10,"city":174,"state":10,"zip":175,"country":165,"countryCode":166,"cosmosGeoPoint":176,"geoPoint":180,"contacts":10},"Nanfang Hospital, Southern Medical University","Guangzhou","510515",{"type":45,"coordinates":177},[178,179],113.25,23.11667,{"lat":179,"lon":178},{"facility":182,"status":10,"city":183,"state":10,"zip":184,"country":165,"countryCode":166,"cosmosGeoPoint":185,"geoPoint":189,"contacts":10},"Tianjin Institute of Hematology & Blood Diseases Hospital","Tianjin","300020",{"type":45,"coordinates":186},[187,188],117.17667,39.14222,{"lat":188,"lon":187},{"facility":191,"status":10,"city":192,"state":10,"zip":193,"country":194,"countryCode":195,"cosmosGeoPoint":196,"geoPoint":200,"contacts":10},"ICIC","San José","1000","Costa Rica","CR",{"type":45,"coordinates":197},[198,199],-84.08489,9.93388,{"lat":199,"lon":198},{"facility":202,"status":10,"city":203,"state":10,"zip":204,"country":205,"countryCode":206,"cosmosGeoPoint":207,"geoPoint":211,"contacts":10},"Universitätsklinikum Bonn (AöR); Inst. für Experimentelle Hämatologie u. Transfusionsmedizin (IHT)","Bonn","53127","Germany","DE",{"type":45,"coordinates":208},[209,210],7.09549,50.73438,{"lat":210,"lon":209},{"facility":213,"status":10,"city":214,"state":215,"zip":216,"country":217,"countryCode":218,"cosmosGeoPoint":219,"geoPoint":223,"contacts":10},"IRCCS Ca' Granda Ospedale Maggiore Policlinico; Centro Emofilia e Trombosi \"Angelo Bianchi e Bonomi\"","Milan","Lombardy","20122","Italy","IT",{"type":45,"coordinates":220},[221,222],9.18951,45.46427,{"lat":222,"lon":221},{"facility":225,"status":10,"city":226,"state":227,"zip":228,"country":217,"countryCode":218,"cosmosGeoPoint":229,"geoPoint":233,"contacts":10},"AOU Careggi; SOD Malattie Emorragiche","Florence","Tuscany","50134",{"type":45,"coordinates":230},[231,232],11.24626,43.77925,{"lat":232,"lon":231},{"facility":235,"status":10,"city":236,"state":10,"zip":237,"country":238,"countryCode":239,"cosmosGeoPoint":240,"geoPoint":244,"contacts":10},"Nagoya University Hospital","Aichi","466-8560","Japan","JP",{"type":45,"coordinates":241},[242,243],130.62158,32.51879,{"lat":243,"lon":242},{"facility":246,"status":10,"city":247,"state":10,"zip":248,"country":238,"countryCode":239,"cosmosGeoPoint":249,"geoPoint":253,"contacts":10},"Hyogo College of Medicine Hospital","Hyōgo","663-8501",{"type":45,"coordinates":250},[251,252],144.43333,43.36667,{"lat":252,"lon":251},{"facility":255,"status":10,"city":256,"state":10,"zip":257,"country":238,"countryCode":239,"cosmosGeoPoint":258,"geoPoint":262,"contacts":10},"St. Marianna University School of Medicine Hospital","Kanagawa","216-8511",{"type":45,"coordinates":259},[260,261],139.91667,37.58333,{"lat":261,"lon":260},{"facility":264,"status":10,"city":265,"state":10,"zip":266,"country":238,"countryCode":239,"cosmosGeoPoint":10,"geoPoint":10,"contacts":10},"Hospital of the University of Occupational and Environmental Health,Japan","Kitakyushu-shi","807-8556",{"facility":268,"status":10,"city":269,"state":10,"zip":270,"country":238,"countryCode":239,"cosmosGeoPoint":271,"geoPoint":275,"contacts":10},"Nara Medical University Hospital","Nara","634-8521",{"type":45,"coordinates":272},[273,274],135.80485,34.68505,{"lat":274,"lon":273},{"facility":277,"status":10,"city":278,"state":10,"zip":279,"country":238,"countryCode":239,"cosmosGeoPoint":280,"geoPoint":284,"contacts":10},"Tokyo Medical University Hospital","Tokyo","160-0023",{"type":45,"coordinates":281},[282,283],139.69171,35.6895,{"lat":283,"lon":282},{"facility":286,"status":10,"city":287,"state":10,"zip":288,"country":289,"countryCode":290,"cosmosGeoPoint":291,"geoPoint":295,"contacts":10},"Uniwersyteckie Centrum Kliniczne; Klinika Hematologii i Transplantologii","Gdansk","80-952","Poland","PL",{"type":45,"coordinates":292},[293,294],18.64912,54.35227,{"lat":294,"lon":293},{"facility":297,"status":10,"city":298,"state":10,"zip":299,"country":289,"countryCode":290,"cosmosGeoPoint":300,"geoPoint":304,"contacts":10},"SPSK Nr1 Klinika Hematoo&Transpl.Szpiku","Lublin","20-081",{"type":45,"coordinates":301},[302,303],22.57009,51.25058,{"lat":303,"lon":302},{"facility":306,"status":10,"city":307,"state":10,"zip":308,"country":289,"countryCode":290,"cosmosGeoPoint":309,"geoPoint":313,"contacts":10},"ALVAMED Lekarskie Gabinety Specjalistyczne","Poznan","61-828",{"type":45,"coordinates":310},[311,312],16.92993,52.40692,{"lat":312,"lon":311},{"facility":315,"status":10,"city":316,"state":10,"zip":317,"country":289,"countryCode":290,"cosmosGeoPoint":318,"geoPoint":322,"contacts":10},"Instytut Hematologii i Transfuzjologii; Klinika Zaburzeń Hemostazy i Chorób Wewnętrznych","Warsaw","02-776",{"type":45,"coordinates":319},[320,321],21.01178,52.22977,{"lat":321,"lon":320},{"facility":324,"status":10,"city":325,"state":10,"zip":326,"country":327,"countryCode":328,"cosmosGeoPoint":329,"geoPoint":333,"contacts":10},"Charlotte Maxeke Johannesburg Hospital; Haemophilia Comprehensive Care Center","Johannesburg","2193","South Africa","ZA",{"type":45,"coordinates":330},[331,332],28.04363,-26.20227,{"lat":332,"lon":331},{"facility":335,"status":10,"city":336,"state":10,"zip":337,"country":338,"countryCode":10,"cosmosGeoPoint":339,"geoPoint":343,"contacts":10},"Severance Hospital","Seoul","03722","South Korea",{"type":45,"coordinates":340},[341,342],126.9784,37.566,{"lat":342,"lon":341},{"facility":345,"status":10,"city":346,"state":10,"zip":347,"country":348,"countryCode":349,"cosmosGeoPoint":350,"geoPoint":354,"contacts":10},"Hospital Universitario la Paz; Servicio de Hematologia","Madrid","28046","Spain","ES",{"type":45,"coordinates":351},[352,353],-3.70256,40.4165,{"lat":353,"lon":352},{"facility":356,"status":10,"city":357,"state":10,"zip":358,"country":348,"countryCode":349,"cosmosGeoPoint":359,"geoPoint":363,"contacts":10},"Hospital Universitario Virgen del Rocio; Servicio de Hematologia","Seville","41013",{"type":45,"coordinates":360},[361,362],-5.97317,37.38283,{"lat":362,"lon":361},{"facility":365,"status":10,"city":366,"state":10,"zip":367,"country":348,"countryCode":349,"cosmosGeoPoint":368,"geoPoint":372,"contacts":10},"Hospital Universitario la Fe; Servicio de Hematologia","Valencia","46026",{"type":45,"coordinates":369},[370,371],-0.37966,39.47391,{"lat":371,"lon":370},{"facility":374,"status":10,"city":375,"state":10,"zip":376,"country":377,"countryCode":378,"cosmosGeoPoint":379,"geoPoint":383,"contacts":10},"National Taiwan Uni Hospital","Taipei","100","Taiwan","TW",{"type":45,"coordinates":380},[381,382],121.52639,25.05306,{"lat":382,"lon":381},{"type":385,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100245706","a-prospective-study-to-collect-high-quality-documentation-of-bleeds-health-related-quality-of-life-hrqol-and-safety-outcomes-in-patients-with-hemophilia-a-treated-with-standard-of-care-treatment-100245706",false,"NCT02476942","A Prospective Study to Collect High-Quality Documentation of Bleeds, Health-Related Quality of Life (HRQoL), and Safety Outcomes in Patients With Hemophilia A Treated With Standard-of-Care Treatment","A Multicenter, Non-Interventional Study Evaluating Bleeding Incidence, Health-Related Quality of Life, and Safety in Patients With Hemophilia A Under Standard-of-Care Treatment","Inclusion Criteria:\n\n* Cohort A: Patients greater than or equal to (\\>\u002F=) 12 years of age at time of informed consent\n* Cohort A: Diagnosis of congenital hemophilia A of any severity and documented history of high-titer inhibitor (that is, \\>\u002F= 5 Bethesda units \\[BU\\])\n* Cohort B: Pediatric patients less than (\\\u003C) 12 years of age\n* Cohort B: Diagnosis of congenital hemophilia A of any severity and documented history of high-titer inhibitor (that is, \\>\u002F=5 BU)\n* Cohort C: Patients \\>\u002F=12 years of age\n* Cohort C: Diagnosis of congenital hemophilia A and FVIII activity \\\u003C1 percent (%)\n* Cohort C: No prior history of a positive inhibitor against FVIII\n\nExclusion Criteria:\n\n* Prior RO5534262 (not applicable if patient agrees that prior RO5534262 will preclude participation in a future investigational RO5534262 study)\n* Bleeding disorder other than congenital hemophilia A\n* Ongoing (or planned during the study) immune tolerance induction therapy with FVIII or FVIII prophylaxis if currently\u002Fpreviously exposed to an inhibitor\n* Previous or concomitant thromboembolic disease\n* Known human immunodeficiency virus (HIV) infection with cluster of differentiation (CD) 4 count \\\u003C200 cells per microliter (cells\u002FmcL)","ALL",{"count":395,"type":396},221,"ACTUAL","OBSERVATIONAL","This non-interventional study will prospectively collect detailed, high-quality documentation of bleeds, HRQoL, and safety in patients with hemophilia A with or without FVIII inhibitors treated according to local routine clinical practice (receiving FVIII replacement or bypassing agents as either episodic or prophylactic treatment). Actual patients will be enrolled from routine clinical practice in this observational study.",[400],"Hemophilia A","COMPLETED","2017-05-26",{"date":404,"type":396},"2017-05-30",{"date":406,"type":396},"2015-05-26",{"date":408,"type":396},"2017-03-31",{"name":5,"class":6},35]