[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100412182":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":29,"locations":41,"responsibleParty":348,"collaborators":350,"id":354,"slug":355,"hasResults":356,"nctId":357,"briefTitle":358,"officialTitle":359,"acronym":56,"eligibilityCriteria":360,"healthyVolunteers":356,"sex":361,"minAge":362,"maxAge":363,"enrollmentInfo":364,"targetDuration":56,"studyType":367,"phases":368,"briefSummary":370,"conditions":371,"keywords":374,"overallStatus":59,"whyStopped":56,"lastUpdateSubmitDate":379,"lastUpdatePostDateStruct":380,"startDateStruct":383,"completionDateStruct":385,"leadSponsor":387,"locationsCount":388},{"fullName":5,"class":6},"American Thrombosis and Hemostasis Network","NETWORK",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Hemophilia A and B Cases","OTHER","SEVENFACT® has been approved for the treatment of bleeding events in individuals with hemophilia A or B with inhibitors. This study is intended to further investigate the safety and tolerability of SEVENFACT in participants with hemophilia A or B with inhibitors in the presence or absence of prophylactic therapies. Dosing will be at the discretion of the attending physician, and each participant will be supplied with the equivalent of nine 75 µg\u002Fkg doses, which aligns with the recommended dosing schedule as provided in SEVENFACT's United States Prescribing Information (USPI). In the event of a bleeding episode (BE), the participant will either self-administer the correct dose under the guidance of the treating investigator or the dose will be administered at a treatment facility.",[13],"Drug: coagulation factor VIIa [recombinant]-jncw",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","coagulation factor VIIa [recombinant]-jncw","a transgenically produced, activated, recombinant, human factor VII (rhFVIIa) protein with the brand name of SEVENFACT®. This protein is a clotting factor in the coagulation cascade that is produced in and purified from the milk of transgenic rabbits. SEVENFACT is approved for the treatment and control of bleeding episodes occurring in adults and adolescents (12 years of age and older) with hemophilia A or B with inhibitors.",[9],[21],"SEVENFACT",[23,26],{"name":24,"affiliation":5,"role":25},"Tammuella Chrisentery-Singleton, MD","PRINCIPAL_INVESTIGATOR",{"name":27,"affiliation":28,"role":25},"Mark Reding, MD","University of Minnesota",[30,36],{"name":31,"role":32,"phone":33,"phoneExt":34,"email":35},"Carol Fedor, ND, RN, CCRC","CONTACT","(800)-360-2846","122","cfedor@athn.org",{"name":37,"role":32,"phone":38,"phoneExt":39,"email":40},"Jessica Callis","800-360-2846","123","jcallis@athn.org",[42,57,75,90,105,115,125,140,154,171,186,197,212,226,235,252,267,282,299,314,333],{"facility":43,"status":44,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Arizona Hemophilia and Thrombosis Center at Phoenix Children's Hospital","COMPLETED","Phoenix","Arizona","85016","United States","US",{"type":51,"coordinates":52},"Point",[53,54],-112.07404,33.44838,{"lat":54,"lon":53},null,{"facility":58,"status":59,"city":60,"state":61,"zip":62,"country":48,"countryCode":49,"cosmosGeoPoint":63,"geoPoint":67,"contacts":68},"Arkansas Center for Bleeding Disorders","RECRUITING","Little Rock","Arkansas","72202",{"type":51,"coordinates":64},[65,66],-92.28959,34.74648,{"lat":66,"lon":65},[69,73],{"name":70,"role":32,"phone":71,"phoneExt":56,"email":72},"Carol Pierce, RN","501-364-1076","piercecarold@uams.edu",{"name":74,"role":25,"phone":56,"phoneExt":56,"email":56},"Shelley Crary, MD",{"facility":76,"status":59,"city":77,"state":78,"zip":79,"country":48,"countryCode":49,"cosmosGeoPoint":80,"geoPoint":84,"contacts":85},"Orthopaedic Institute for Children","Los Angeles","California","90007",{"type":51,"coordinates":81},[82,83],-118.24368,34.05223,{"lat":83,"lon":82},[86,89],{"name":87,"role":32,"phone":56,"phoneExt":56,"email":88},"Doris Quon, MD","dquon@mednet.ucla.edu",{"name":87,"role":25,"phone":56,"phoneExt":56,"email":56},{"facility":91,"status":59,"city":92,"state":78,"zip":93,"country":48,"countryCode":49,"cosmosGeoPoint":94,"geoPoint":98,"contacts":99},"University of California at Davis UC Davis Hemostasis and Thrombosis Center","Sacramento","95817",{"type":51,"coordinates":95},[96,97],-121.4944,38.58157,{"lat":97,"lon":96},[100,103],{"name":101,"role":32,"phone":56,"phoneExt":56,"email":102},"Celynn Knight","ceknight@ucdavis.edu",{"name":104,"role":25,"phone":56,"phoneExt":56,"email":56},"Kim Schafer, RN, FNP",{"facility":106,"status":44,"city":107,"state":108,"zip":109,"country":48,"countryCode":49,"cosmosGeoPoint":110,"geoPoint":114,"contacts":56},"Children's National Hemophilia Center","Washington D.C.","District of Columbia","20010",{"type":51,"coordinates":111},[112,113],-77.03637,38.89511,{"lat":113,"lon":112},{"facility":116,"status":44,"city":117,"state":118,"zip":119,"country":48,"countryCode":49,"cosmosGeoPoint":120,"geoPoint":124,"contacts":56},"Arnold Palmer Hospital for Children - The Haley Center for Children's Cancer and Blood Disorders","Orlando","Florida","32806",{"type":51,"coordinates":121},[122,123],-81.37924,28.53834,{"lat":123,"lon":122},{"facility":126,"status":59,"city":127,"state":128,"zip":129,"country":48,"countryCode":49,"cosmosGeoPoint":130,"geoPoint":134,"contacts":135},"Hemophilia of Georgia Center for Bleeding and Clotting Disorders of Emory, Adult Division","Atlanta","Georgia","31404",{"type":51,"coordinates":131},[132,133],-84.38798,33.749,{"lat":133,"lon":132},[136,139],{"name":137,"role":32,"phone":56,"phoneExt":56,"email":138},"Megan Brown, MD","megan.brown@emory.edu",{"name":137,"role":25,"phone":56,"phoneExt":56,"email":56},{"facility":141,"status":59,"city":142,"state":128,"zip":129,"country":48,"countryCode":49,"cosmosGeoPoint":143,"geoPoint":147,"contacts":148},"Willett Children's Hospital at Memorial University Medical Center","Savannah",{"type":51,"coordinates":144},[145,146],-81.09983,32.08354,{"lat":146,"lon":145},[149,152],{"name":150,"role":32,"phone":56,"phoneExt":56,"email":151},"Alta Castellano, RN","Alta.Castellino@hcahealthcare.com",{"name":153,"role":25,"phone":56,"phoneExt":56,"email":56},"Ashley Eason",{"facility":155,"status":59,"city":156,"state":157,"zip":158,"country":48,"countryCode":49,"cosmosGeoPoint":159,"geoPoint":163,"contacts":164},"Massachusetts General Hospital Comprehensive Hemophilia and Thrombosis Treatment Center","Boston","Massachusetts","02114",{"type":51,"coordinates":160},[161,162],-71.05977,42.35843,{"lat":162,"lon":161},[165,169],{"name":166,"role":32,"phone":167,"phoneExt":56,"email":168},"Carmen Zhou","617-726-2737","czhou12@mgh.harvard.edu",{"name":170,"role":25,"phone":56,"phoneExt":56,"email":56},"Eric Grabowski, MD",{"facility":172,"status":59,"city":173,"state":174,"zip":175,"country":48,"countryCode":49,"cosmosGeoPoint":176,"geoPoint":180,"contacts":181},"Children's Hospital of Michigan","Detroit","Michigan","48201",{"type":51,"coordinates":177},[178,179],-83.04575,42.33143,{"lat":179,"lon":178},[182,185],{"name":183,"role":32,"phone":56,"phoneExt":56,"email":184},"Meera Chitlur, MD","mchitlur@dmc.org",{"name":183,"role":25,"phone":56,"phoneExt":56,"email":56},{"facility":187,"status":59,"city":173,"state":174,"zip":188,"country":48,"countryCode":49,"cosmosGeoPoint":189,"geoPoint":191,"contacts":192},"Henry Ford Health System","48202",{"type":51,"coordinates":190},[178,179],{"lat":179,"lon":178},[193,196],{"name":194,"role":32,"phone":56,"phoneExt":56,"email":195},"Philip Kuriakose, MD","pkuriak1@hfhs.org",{"name":194,"role":25,"phone":56,"phoneExt":56,"email":56},{"facility":198,"status":59,"city":199,"state":174,"zip":200,"country":48,"countryCode":49,"cosmosGeoPoint":201,"geoPoint":205,"contacts":206},"MSU Center for Bleeding and Clotting Disorders","Lansing","48912",{"type":51,"coordinates":202},[203,204],-84.55553,42.73253,{"lat":204,"lon":203},[207,210],{"name":208,"role":32,"phone":56,"phoneExt":56,"email":209},"Anna Burghardt","annarn@msu.edu",{"name":211,"role":25,"phone":56,"phoneExt":56,"email":56},"Shiva Shrotriya, MD",{"facility":213,"status":214,"city":215,"state":216,"zip":217,"country":48,"countryCode":49,"cosmosGeoPoint":218,"geoPoint":222,"contacts":223},"Center for Bleeding and Clotting Disorders, University of Minnesota","NOT_YET_RECRUITING","Minneapolis","Minnesota","55455",{"type":51,"coordinates":219},[220,221],-93.26384,44.97997,{"lat":221,"lon":220},[224,225],{"name":27,"role":32,"phone":56,"phoneExt":56,"email":56},{"name":27,"role":25,"phone":56,"phoneExt":56,"email":56},{"facility":227,"status":44,"city":228,"state":216,"zip":229,"country":48,"countryCode":49,"cosmosGeoPoint":230,"geoPoint":234,"contacts":56},"Mayo Comprehensive Hemophilia Center","Rochester","55905",{"type":51,"coordinates":231},[232,233],-92.4699,44.02163,{"lat":233,"lon":232},{"facility":236,"status":59,"city":237,"state":238,"zip":239,"country":48,"countryCode":49,"cosmosGeoPoint":240,"geoPoint":244,"contacts":245},"Kansas City Regional Hemophilia Center","Kansas City","Missouri","64108",{"type":51,"coordinates":241},[242,243],-94.57857,39.09973,{"lat":243,"lon":242},[246,250],{"name":247,"role":32,"phone":248,"phoneExt":56,"email":249},"Eryn Bilynsky","816-302-6853","erbilynsky@cmh.edu",{"name":251,"role":25,"phone":56,"phoneExt":56,"email":56},"Lauren Amos, MD",{"facility":253,"status":59,"city":254,"state":255,"zip":256,"country":48,"countryCode":49,"cosmosGeoPoint":257,"geoPoint":261,"contacts":262},"Northwell Health, Long Island Jewish","New Hyde Park","New York","11040",{"type":51,"coordinates":258},[259,260],-73.68791,40.7351,{"lat":260,"lon":259},[263,266],{"name":264,"role":32,"phone":56,"phoneExt":56,"email":265},"Suchitra Acharya, MD","Sacharya@northwell.edu",{"name":264,"role":25,"phone":56,"phoneExt":56,"email":56},{"facility":268,"status":214,"city":269,"state":270,"zip":271,"country":48,"countryCode":49,"cosmosGeoPoint":272,"geoPoint":276,"contacts":277},"Brody School of Medicine at East Carolina University","Greenville","North Carolina","27834",{"type":51,"coordinates":273},[274,275],-77.36635,35.61266,{"lat":275,"lon":274},[278,280],{"name":279,"role":32,"phone":56,"phoneExt":56,"email":56},"Darla Liles",{"name":281,"role":25,"phone":56,"phoneExt":56,"email":56},"Darla Liles, MD",{"facility":283,"status":59,"city":284,"state":285,"zip":286,"country":48,"countryCode":49,"cosmosGeoPoint":287,"geoPoint":291,"contacts":292},"University Hospitals Health System Cleveland","Cleveland","Ohio","44106",{"type":51,"coordinates":288},[289,290],-81.69541,41.4995,{"lat":290,"lon":289},[293,297],{"name":294,"role":32,"phone":295,"phoneExt":56,"email":296},"Julia Martiradonna","216-844-3329","Julia.martiradonna@uhhospitals.org",{"name":298,"role":25,"phone":56,"phoneExt":56,"email":56},"John Letterio, MD",{"facility":300,"status":59,"city":301,"state":302,"zip":303,"country":48,"countryCode":49,"cosmosGeoPoint":304,"geoPoint":308,"contacts":309},"Oklahoma Center for Bleeding and Clotting Disorders","Oklahoma City","Oklahoma","73104",{"type":51,"coordinates":305},[306,307],-97.51643,35.46756,{"lat":307,"lon":306},[310,313],{"name":311,"role":32,"phone":56,"phoneExt":56,"email":312},"Osman Khan, MD","osman-khan@ouhsc.edu",{"name":311,"role":25,"phone":56,"phoneExt":56,"email":56},{"facility":315,"status":59,"city":316,"state":317,"zip":318,"country":48,"countryCode":49,"cosmosGeoPoint":319,"geoPoint":323,"contacts":324},"Vanderbilt University Medical Center","Nashville","Tennessee","37212",{"type":51,"coordinates":320},[321,322],-86.78444,36.16589,{"lat":322,"lon":321},[325,328,330],{"name":326,"role":32,"phone":56,"phoneExt":56,"email":327},"Alyssa Weakley","alyssa.weakley@vumc.org",{"name":329,"role":25,"phone":56,"phoneExt":56,"email":56},"Shannon Walker, MD",{"name":331,"role":332,"phone":56,"phoneExt":56,"email":56},"Michelle Chi, MD","SUB_INVESTIGATOR",{"facility":334,"status":59,"city":335,"state":336,"zip":337,"country":48,"countryCode":49,"cosmosGeoPoint":338,"geoPoint":342,"contacts":343},"Gulf States Hemophilia and Thrombophilia Center-University of Texas Health Science Center @Houston","Houston","Texas","77030",{"type":51,"coordinates":339},[340,341],-95.36327,29.76328,{"lat":341,"lon":340},[344,347],{"name":345,"role":32,"phone":56,"phoneExt":56,"email":346},"Miguel Escobar, MD","Miguel.Escobar@uth.tmc.edu",{"name":345,"role":25,"phone":56,"phoneExt":56,"email":56},{"type":349,"investigatorFullName":56,"investigatorTitle":56,"investigatorAffiliation":56,"oldNameTitle":56,"oldOrganization":56},"SPONSOR",[351],{"name":352,"class":353},"LFB USA, Inc.","INDUSTRY","100412182","phase-4-sevenfact-for-bleeding-events-in-hemophilia-with-inhibitors-100412182",false,"NCT04647227","SEVENFACT® for Bleeding Events in Hemophilia With Inhibitors","Safety of SEVENFACT® for the Treatment of Bleeding Events in Patients With Hemophilia A or B With Inhibitors","Inclusion Criteria:\n\n1. Have a diagnosis of hemophilia A or B with inhibitors.\n2. Be 12 years of age and older\n3. Be capable of understanding and willing to comply with the conditions of the protocol or have a legal guardian who is capable of understanding and complying with the conditions of the protocol\n4. Have read, understood, and documented written informed consent\u002Fassent\n5. Be able to provide medical evidence through prior medical history of previous inhibitor levels\n6. Be willing and able to use the ATHN mobile application or a paper diary to document BEs and medication usage\n\nExclusion Criteria:\n\n1. Have a disorder of hemostasis in addition to Hemophilia A or B\n2. Have a known or suspected intolerance or hypersensitivity to SEVENFACT® or its ingredients\n3. Have a known allergy or hypersensitivity to rabbits or rabbit proteins\n4. Are receiving prophylactic treatment for bleeding with a drug or biologic that is not approved for this use by the FDA\n5. Have had implantation of an investigational medical device within the prior 6 months\n6. Have received an investigational drug within 30 days of the baseline visit\n7. Have an elective surgical procedure planned during the duration of their participation in the study\\*\n8. Have any life-threatening disease, or other disease or condition which, in the investigator's judgment, could pose a potential hazard to the patient or interfere with study participation or study outcome (e.g., a history of non responsiveness to bypassing products or thromboembolic disease)\n\n   * Should a participant require an unplanned surgery, the participant will not be withdrawn from the study unless the investigator deems it necessary. Instead, the participant will receive standard of care treatment as determined by the attending physician. If the participant is not withdrawn from the study, the participant's participation in the study will be paused until the investigator feels it is safe for them to continue.","ALL","12 Years","100 Years",{"count":365,"type":366},55,"ESTIMATED","INTERVENTIONAL",[369],"PHASE4","Phase IV multi-center, US-centric, open-label, safety study enrolling participants with Hemophilia A or B with inhibitors, 12 years of age and older, who are either on long term prophylactic treatment (e.g., emicizumab) at risk of experiencing a breakthrough bleeding event (BE), or who are not on prophylactic treatment who may need to control a BE.",[372,373],"Hemophilia A With Inhibitor","Hemophilia B With Inhibitor",[375,376,377,378],"Hemophilia A","Hemophilia B","bleeding event","prophylactic treatment","2026-01-09",{"date":381,"type":382},"2026-01-12","ACTUAL",{"date":384,"type":382},"2021-06-28",{"date":386,"type":366},"2027-03-31",{"name":5,"class":6},21]