{"id":"biib031-rfviiifc","safety":{"commonSideEffects":[{"rate":null,"effect":"Inhibitor development (anti-Factor VIII antibodies)"},{"rate":null,"effect":"Injection site reactions"},{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Hypersensitivity reactions"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"This fusion protein combines the coagulation activity of Factor VIII with the extended half-life properties conferred by the Fc domain, allowing for less frequent dosing. The Fc fusion reduces the immunogenicity and clearance of Factor VIII, improving pharmacokinetics while maintaining hemostatic efficacy in patients with Factor VIII deficiency.","oneSentence":"rFVIIIFc is a recombinant Factor VIII fused to the Fc domain of human immunoglobulin G, which replaces deficient clotting Factor VIII to restore hemostatic function in hemophilia A.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T01:04:21.074Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Hemophilia A (treatment and prophylaxis of bleeding episodes)"}]},"trialDetails":[{"nctId":"NCT02234323","phase":"PHASE3","title":"An Open Label Study to Determine the Safety and Efficacy of Replacement Factor VIII Protein (Known as rFVIIIFc) in Previously Untreated Males With Severe Hemophilia A","status":"COMPLETED","sponsor":"Bioverativ, a Sanofi company","startDate":"2015-01-12","conditions":"Hemophilia A","enrollment":108},{"nctId":"NCT03093480","phase":"PHASE4","title":"A Study to Evaluate Efficacy of rFVIIIFc for Immune Tolerance Induction (ITI) in Severe Hemophilia A Participants With Inhibitors Undergoing the First ITI Treatment (verITI-8 Study)","status":"COMPLETED","sponsor":"Bioverativ, a Sanofi company","startDate":"2017-12-08","conditions":"Hemophilia A With Inhibitors","enrollment":16},{"nctId":"NCT02083965","phase":"PHASE1","title":"Pharmacokinetics of rFVIIIFc at Two Vial Strengths","status":"COMPLETED","sponsor":"Bioverativ Therapeutics Inc.","startDate":"2014-03","conditions":"Severe Hemophilia A","enrollment":19},{"nctId":"NCT01458106","phase":"PHASE3","title":"Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Recombinant Coagulation Factor VIII Fc Fusion Protein (rFVIIIFc) in Previously Treated Pediatric Subjects With Hemophilia A","status":"COMPLETED","sponsor":"Bioverativ Therapeutics Inc.","startDate":"2012-11","conditions":"Hemophilia A","enrollment":71},{"nctId":"NCT02502149","phase":"PHASE3","title":"Pharmacokinetics and Safety of rFVIIIFc Manufactured at 15,000 L (15K) Scale","status":"COMPLETED","sponsor":"Bioverativ Therapeutics Inc.","startDate":"2015-08","conditions":"Severe Hemophilia A","enrollment":24},{"nctId":"NCT01454739","phase":"PHASE3","title":"Long-Term Safety and Efficacy of rFVIIIFc in the Prevention and Treatment of Bleeding Episodes in Previously Treated Participants With Hemophilia A","status":"COMPLETED","sponsor":"Bioverativ Therapeutics Inc.","startDate":"2011-12","conditions":"Hemophilia A","enrollment":240},{"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":132,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["ELOCTATE","efmoroctocog alfa","antihemophilic factor (recombinant), Fc fusion protein","recombinant coagulation factor VIII Fc fusion protein"],"phase":"phase_3","status":"active","brandName":"BIIB031 (rFVIIIFc)","genericName":"BIIB031 (rFVIIIFc)","companyName":"Bioverativ Therapeutics Inc.","companyId":"bioverativ-therapeutics-inc","modality":"Small molecule","firstApprovalDate":"","aiSummary":"rFVIIIFc is a recombinant Factor VIII fused to the Fc domain of human immunoglobulin G, which replaces deficient clotting Factor VIII to restore hemostatic function in hemophilia A. Used for Hemophilia A (treatment and prophylaxis 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}}