{"id":"factor-viii-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":{"chemblId":"CHEMBL2108175","moleculeType":"Unknown"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Factor VIII is a critical blood coagulation protein that is deficient or dysfunctional in hemophilia A. The recombinant Factor VIII (rFVIII) is produced through genetic engineering, and the addition of the Fc domain extends the half-life of the protein in circulation, allowing for less frequent dosing compared to conventional Factor VIII products. This fusion protein restores the intrinsic coagulation pathway and enables normal thrombin generation.","oneSentence":"rFVIIIFc is a recombinant Factor VIII protein fused to the Fc domain of human immunoglobulin G, which replaces deficient clotting Factor VIII to restore hemostasis in hemophilia A patients.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T01:12:12.483Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Hemophilia A (treatment and prophylaxis of bleeding episodes)"}]},"trialDetails":[{"nctId":"NCT04293523","phase":"","title":"A 48-Month Study to Evaluate Long-Term Effectiveness of Elocta on Joint Health","status":"ACTIVE_NOT_RECRUITING","sponsor":"Swedish Orphan Biovitrum","startDate":"2020-03-30","conditions":"Hemophilia A","enrollment":427},{"nctId":"NCT06579144","phase":"PHASE1","title":"Pharmacokinetic Comparison of Efanesoctocog Alfa vs Other EHL-rFVIII Products in Participants With Severe Haemophilia A","status":"RECRUITING","sponsor":"Swedish Orphan Biovitrum","startDate":"2025-02-24","conditions":"Hemophilia A","enrollment":24},{"nctId":"NCT06716814","phase":"PHASE3","title":"Study to Provide Continued Access to Treatment for Patients Completing a Previous Trial With Efanesoctocog Alfa","status":"RECRUITING","sponsor":"Swedish Orphan Biovitrum","startDate":"2025-03-06","conditions":"Severe Haemophilia A","enrollment":104},{"nctId":"NCT05817812","phase":"PHASE3","title":"A Study Evaluating Physical Activity and Joint Health in Severe Haemophilia A Patients ≥12 Years Treated Once Weekly With Efanesoctocog Alfa","status":"ACTIVE_NOT_RECRUITING","sponsor":"Swedish Orphan Biovitrum","startDate":"2023-07-31","conditions":"Hemophilia A, Severe","enrollment":93},{"nctId":"NCT04161495","phase":"PHASE3","title":"A Phase 3 Open-label Interventional Study of Intravenous Recombinant Coagulation Factor VIII Fc-von Willebrand Factor-XTEN Fusion Protein, Efanesoctocog Alfa (BIVV001), in Patients With Severe Hemophilia A","status":"COMPLETED","sponsor":"Bioverativ, a Sanofi company","startDate":"2019-11-19","conditions":"Factor VIII Deficiency","enrollment":159},{"nctId":"NCT04759131","phase":"PHASE3","title":"Safety, Efficacy and PK of BIVV001 in Pediatric Patients With Hemophilia A","status":"COMPLETED","sponsor":"Bioverativ, a Sanofi company","startDate":"2021-02-19","conditions":"Hemophilia A","enrollment":74},{"nctId":"NCT04644575","phase":"PHASE3","title":"Long-term Safety and Efficacy of Efanesoctocog Alfa (BIVV001) in Previously Treated Patients With Hemophilia A","status":"ACTIVE_NOT_RECRUITING","sponsor":"Bioverativ, a Sanofi company","startDate":"2021-02-23","conditions":"Hemophilia A","enrollment":261},{"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":"NCT03951103","phase":"","title":"rFVIIIFc (Elocta®) ITI Chart Review in Patients With Haemophilia A","status":"COMPLETED","sponsor":"Swedish Orphan Biovitrum","startDate":"2018-11-07","conditions":"Hemophilia A With Inhibitor","enrollment":44},{"nctId":"NCT03103542","phase":"PHASE4","title":"Study of rFVIIIFc for Immune Tolerance Induction (ITI) in Haemophilia A Patients With Inhibitors Who Have Failed Previous ITI Therapies","status":"COMPLETED","sponsor":"Swedish Orphan Biovitrum","startDate":"2017-08-29","conditions":"Hemophilia A","enrollment":16},{"nctId":"NCT05981274","phase":"","title":"A Study on the Bone-health Effectiveness of Applying Recombinant Factor VIII Fc (rFVIIIFc) to Patients With Hemophilia A (Prototype A)","status":"RECRUITING","sponsor":"Tri-Service General Hospital","startDate":"2023-07-14","conditions":"Severe Hemophilia A Without Inhibitor","enrollment":45},{"nctId":"NCT04303559","phase":"PHASE3","title":"The Hemophilia Inhibitor Prevention Trial","status":"TERMINATED","sponsor":"Margaret Ragni","startDate":"2021-10-11","conditions":"Hemophilia A Without Inhibitor","enrollment":1},{"nctId":"NCT04303572","phase":"PHASE3","title":"The Hemophilia Inhibitor Eradication Trial","status":"TERMINATED","sponsor":"Margaret Ragni","startDate":"2021-11-01","conditions":"Hemophilia A With Inhibitor","enrollment":1},{"nctId":"NCT03205163","phase":"PHASE1, PHASE2","title":"A Safety, Tolerability, and Pharmacokinetics Study of a Single Intravenous Injection of Recombinant Coagulation Factor VIII Fc - Von Willebrand Factor - XTEN Fusion Protein (rFVIIIFc-VWF-XTEN) (BIVV001) in Previously Treated Adults With Severe Hemophilia A (EXTEN-A)","status":"COMPLETED","sponsor":"Bioverativ, a Sanofi company","startDate":"2017-08-28","conditions":"Hemophilia A","enrollment":16},{"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":"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":"NCT01181128","phase":"PHASE3","title":"Study to Evaluate the Safety, Pharmacokinetics and Efficacy of Recombinant Factor VIII Fc Fusion Protein (rFVIIIFc) in Previously Treated Subjects With Severe Hemophilia A","status":"COMPLETED","sponsor":"Bioverativ Therapeutics Inc.","startDate":"2010-11","conditions":"Severe Hemophilia A","enrollment":165},{"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},{"nctId":"NCT01027377","phase":"PHASE1","title":"Study of Recombinant Factor VIII Fc Fusion Protein (rFVIIIFc) in Subjects With Severe Hemophilia A","status":"COMPLETED","sponsor":"Bioverativ Therapeutics Inc.","startDate":"2009-12","conditions":"Severe Hemophilia A","enrollment":16},{"nctId":"NCT02196207","phase":"PHASE3","title":"Hemophilia Inhibitor Clinical Trials (INHIBIT) Platform","status":"WITHDRAWN","sponsor":"Margaret Ragni","startDate":"2020-08","conditions":"Severe Hemophilia A","enrollment":""}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":126,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Recombinant Factor VIII Fc Fusion Protein"],"phase":"phase_3","status":"active","brandName":"Factor VIII (rFVIIIFc)","genericName":"Factor VIII (rFVIIIFc)","companyName":"Bioverativ Therapeutics Inc.","companyId":"bioverativ-therapeutics-inc","modality":"Small molecule","firstApprovalDate":"","aiSummary":"rFVIIIFc is a recombinant Factor VIII protein fused to the Fc domain of human immunoglobulin G, which replaces deficient clotting Factor VIII to restore hemostasis in hemophilia A patients. 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}}