{"id":"factor-ix-rfixfc","safety":{"commonSideEffects":[{"rate":null,"effect":"Injection site reactions"},{"rate":null,"effect":"Inhibitor development (anti-Factor IX antibodies)"},{"rate":null,"effect":"Thrombotic events"},{"rate":null,"effect":"Headache"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"This fusion protein combines the catalytic activity of Factor IX with the extended half-life properties conferred by the Fc domain, allowing for less frequent dosing compared to conventional Factor IX products. The Fc fusion extends circulating half-life by approximately 2–3 fold, improving pharmacokinetics and reducing treatment burden in hemophilia B management.","oneSentence":"Factor IX (rFIXFc) is a recombinant clotting factor IX fused to the Fc domain of human immunoglobulin G, which replaces deficient Factor IX to restore blood coagulation in hemophilia B patients.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T01:12:15.133Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Hemophilia B (Factor IX deficiency) — routine prophylaxis and on-demand treatment of bleeding episodes"}]},"trialDetails":[{"nctId":"NCT03901755","phase":"","title":"An International Study to Evaluate the Real-world Effectiveness and Usage of Alprolix in Patients With Haemophilia B","status":"COMPLETED","sponsor":"Swedish Orphan Biovitrum","startDate":"2019-09-12","conditions":"Hemophilia B","enrollment":151},{"nctId":"NCT03055611","phase":"","title":"A Study to Evaluate the Real-world Usage and Effectiveness of Elocta and Alprolix in Patients With Haemophilia A or B","status":"COMPLETED","sponsor":"Swedish Orphan Biovitrum","startDate":"2017-05-09","conditions":"Haemophilia A, Haemophilia B","enrollment":201},{"nctId":"NCT03655340","phase":"","title":"A Study to Evaluate the Real-world Effectiveness and Usage of Alprolix in Patients With Haemophilia B in France","status":"COMPLETED","sponsor":"Swedish Orphan Biovitrum","startDate":"2018-09-12","conditions":"Haemophilia B","enrollment":91},{"nctId":"NCT02234310","phase":"PHASE3","title":"Study to Determine the Safety and Efficacy of rFIXFc in Previously Untreated Males With Severe Hemophilia B","status":"COMPLETED","sponsor":"Bioverativ, a Sanofi company","startDate":"2014-11-13","conditions":"Hemophilia B","enrollment":33},{"nctId":"NCT02796222","phase":"","title":"Factor Product Utilization and Health Outcomes in Patients With Hemophilia","status":"COMPLETED","sponsor":"University of British Columbia","startDate":"2016-04","conditions":"Hemophilia A, Congenital, Hemophilia B, Congenital","enrollment":61},{"nctId":"NCT01027364","phase":"PHASE3","title":"Study of Recombinant Factor IX Fc Fusion Protein (rFIXFc) in Participants With Hemophilia B","status":"COMPLETED","sponsor":"Bioverativ Therapeutics Inc.","startDate":"2009-12","conditions":"Severe Hemophilia B","enrollment":123},{"nctId":"NCT01440946","phase":"PHASE3","title":"Study of Recombinant Coagulation Factor IX Fc Fusion Protein, BIIB029, in Previously Treated Pediatric Participants With Hemophilia B","status":"COMPLETED","sponsor":"Bioverativ Therapeutics Inc.","startDate":"2012-06","conditions":"Hemophilia B","enrollment":30},{"nctId":"NCT00716716","phase":"PHASE1","title":"Phase I/IIa Study of FIXFc in Hemophilia B Patients","status":"COMPLETED","sponsor":"Bioverativ Therapeutics Inc.","startDate":"2008-04","conditions":"Hemophilia B","enrollment":10},{"nctId":"NCT01425723","phase":"PHASE3","title":"Long-Term Safety and Efficacy of rFIXFc in the Prevention and Treatment of Bleeding Episodes in Previously Treated Participants With Hemophilia B","status":"COMPLETED","sponsor":"Bioverativ Therapeutics Inc.","startDate":"2011-12-08","conditions":"Severe Hemophilia B","enrollment":120},{"nctId":"NCT02392156","phase":"","title":"Fc factOrs and Real-World hemophiliA Patient-ReporteD Outcomes","status":"TERMINATED","sponsor":"Bioverativ Therapeutics Inc.","startDate":"2015-07","conditions":"Hemophilia A, Hemophilia B","enrollment":3}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":0,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Recombinant Human Factor IX Fc Fusion Protein"],"phase":"phase_3","status":"active","brandName":"Factor IX (rFIXFc)","genericName":"Factor IX (rFIXFc)","companyName":"Bioverativ Therapeutics Inc.","companyId":"bioverativ-therapeutics-inc","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Factor IX (rFIXFc) is a recombinant clotting factor IX fused to the Fc domain of human immunoglobulin G, which replaces deficient Factor IX to restore blood coagulation in hemophilia B patients. Used for Hemophilia B (Factor IX deficiency) — routine prophylaxis and on-demand treatment of bleeding episodes.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}