{"id":"rviii-singlechain","safety":{"commonSideEffects":[{"rate":null,"effect":"Inhibitor development (factor VIII antibodies)"},{"rate":null,"effect":"Injection site reactions"},{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Hypersensitivity reactions"}]},"_chembl":{"chemblId":"CHEMBL4594603","moleculeType":"Protein"},"_dailymed":null,"mechanism":{"_ai_source":"anthropic-haiku","explanation":"This is a genetically engineered factor VIII molecule designed as a single polypeptide chain (rather than the natural two-chain structure) to improve stability and potentially reduce immunogenicity. It functions as a cofactor in the intrinsic coagulation pathway, enabling thrombin generation and clot formation in patients with factor VIII deficiency.","oneSentence":"rVIII-SingleChain is a recombinant single-chain factor VIII that replaces deficient clotting factor VIII to restore hemostasis in hemophilia A patients.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:33:01.272Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Hemophilia A (treatment and prophylaxis of bleeding episodes)"}]},"trialDetails":[{"nctId":"NCT06738485","phase":"PHASE3","title":"Recombinant Single-chain Factor VIII (rVIII-SingleChain) in Chinese Participants With Hemophilia A Previously Treated With FVIII Products","status":"RECRUITING","sponsor":"CSL Behring","startDate":"2025-01-09","conditions":"Congenital Hemophilia A","enrollment":60},{"nctId":"NCT02172950","phase":"PHASE3","title":"An Open-label Safety and Efficacy Study of Recombinant FVIII in Patients With Severe Hemophilia A","status":"COMPLETED","sponsor":"CSL Behring","startDate":"2014-10-13","conditions":"Hemophilia A, Severe Hemophilia A","enrollment":246},{"nctId":"NCT02093897","phase":"PHASE3","title":"Pharmacokinetic, Efficacy, and Safety Study of Recombinant Factor VIII Single Chain (rVIII-SingleChain) in Children With Severe Hemophilia A","status":"COMPLETED","sponsor":"CSL Behring","startDate":"2014-03","conditions":"Congenital Hemophilia A","enrollment":84},{"nctId":"NCT01486927","phase":"PHASE2, PHASE3","title":"An Open-label Safety, Efficacy and Pharmacokinetic Study of a Recombinant FVIII Compared to Recombinant Human Antihemophilic FVIII in Patients With Severe Hemophilia A","status":"COMPLETED","sponsor":"CSL Behring","startDate":"2012-02","conditions":"Hemophilia A","enrollment":175}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":31,"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 single chain","CSL627","Recombinant Factor VIII (rFVIII)"],"phase":"phase_3","status":"active","brandName":"rVIII-SingleChain","genericName":"rVIII-SingleChain","companyName":"CSL Behring","companyId":"csl-behring","modality":"Biologic","firstApprovalDate":"","aiSummary":"rVIII-SingleChain is a recombinant single-chain factor VIII that 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":1,"withResults":1},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}