{"id":"fviii-pk-subgroup-only","safety":{"commonSideEffects":[{"rate":null,"effect":"Inhibitor development (anti-FVIII antibodies)"},{"rate":null,"effect":"Injection site reactions"},{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Fever"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Factor VIII is a critical cofactor in the intrinsic coagulation cascade that works with von Willebrand factor and factor IX to activate factor X, ultimately leading to thrombin generation and fibrin clot formation. In hemophilia A, deficiency or dysfunction of factor VIII impairs this cascade, resulting in bleeding tendency. Recombinant FVIII replacement therapy restores coagulation capacity and prevents or treats bleeding episodes. The PK subgroup designation indicates this study focuses on pharmacokinetic characterization of the factor VIII product.","oneSentence":"FVIII is a recombinant coagulation factor VIII that replaces deficient or dysfunctional clotting factor to restore hemostasis in hemophilia A patients.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:13:38.120Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Hemophilia A (factor VIII deficiency) — prevention and treatment of bleeding episodes"}]},"trialDetails":[{"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":"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":"NCT03622476","phase":"PHASE4","title":"Pharmacokinetic (PK)Research on Chinese Children of Hemophilia","status":"UNKNOWN","sponsor":"Beijing Children's Hospital","startDate":"2018-06-30","conditions":"Pharmacokinetics","enrollment":155}],"_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":[],"phase":"phase_3","status":"active","brandName":"FVIII (PK subgroup only)","genericName":"FVIII (PK subgroup only)","companyName":"Bioverativ Therapeutics Inc.","companyId":"bioverativ-therapeutics-inc","modality":"Small molecule","firstApprovalDate":"","aiSummary":"FVIII (PK subgroup) is a small molecule used to treat severe Hemophilia A and study its pharmacokinetics. It is administered as concentrated FVIII or Factor VIII (rFVIIIFc), such as Advate, to patients with Hemophilia A.","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}