{"id":"human-cl-rhfviii","safety":{"commonSideEffects":[{"rate":null,"effect":"Inhibitor development (anti-Factor VIII 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 pathway that works with von Willebrand factor to activate Factor X. In hemophilia A, Factor VIII is absent or defective, leading to impaired thrombin generation and bleeding. Recombinant Factor VIII replacement therapy restores normal coagulation cascade function and hemostatic capacity.","oneSentence":"Human cl rhFVIII is a recombinant human Factor VIII that replaces deficient or dysfunctional clotting factor VIII to restore blood coagulation in hemophilia A patients.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T00:48:02.171Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Hemophilia A (congenital Factor VIII deficiency)"}]},"trialDetails":[{"nctId":"NCT04046848","phase":"PHASE1, PHASE2","title":"Safety and Pharmacokinetics of Subcutaneous Injection of OCTA101 in Adult Patients With Severe Hemophilia A","status":"TERMINATED","sponsor":"Octapharma","startDate":"2019-07-03","conditions":"Severe Hemophilia A","enrollment":36},{"nctId":"NCT02962765","phase":"","title":"Non-interventional Post-authorisation Study to Document the Immunogenicity, Safety, and Efficacy of NUWIQ","status":"COMPLETED","sponsor":"Octapharma","startDate":"2015-01","conditions":"Hemophilia A","enrollment":80},{"nctId":"NCT01992549","phase":"PHASE3","title":"Study to Investigate Immunogenicity, Efficacy and Safety of Treatment With Human-cl rhFVIII","status":"COMPLETED","sponsor":"Octapharma","startDate":"2014-04","conditions":"Severe Hemophilia A","enrollment":48},{"nctId":"NCT02256917","phase":"PHASE3","title":"Assess the Efficacy and Safety of Personalized Prophylaxis Human-cl rhFVIII in Patients With Severe Haemophilia A","status":"COMPLETED","sponsor":"Octapharma","startDate":"2015-05","conditions":"Severe Haemophilia A","enrollment":58},{"nctId":"NCT01712438","phase":"PHASE3","title":"Human Cell Line-derived Recombinant Factor VIII (Human-cl-rhFVIII) in Previously Untreated Patients","status":"COMPLETED","sponsor":"Octapharma","startDate":"2013-02","conditions":"Severe Hemophilia A","enrollment":110},{"nctId":"NCT01341912","phase":"PHASE3","title":"Study to Investigate the Long-term Efficacy and Safety of Human-cl rhFVIII in Previously Treated Patients (PTPs)","status":"COMPLETED","sponsor":"Octapharma","startDate":"2011-06","conditions":"Severe Hemophilia A","enrollment":3},{"nctId":"NCT00989196","phase":"PHASE2","title":"Clinical Study to Investigate the Pharmacokinetics, Efficacy, Safety and Immunogenicity of a Recombinant FVIII in Patients With Severe Hemophilia A","status":"COMPLETED","sponsor":"Octapharma","startDate":"2010-05","conditions":"Hemophilia A","enrollment":22},{"nctId":"NCT01863758","phase":"PHASE3","title":"Assess the Safety and Efficacy of Individually Tailored Prophylaxis With Human-cl rhFVIII in Patients With Severe Haemophilia A","status":"COMPLETED","sponsor":"Octapharma","startDate":"2013-08","conditions":"Severe Haemophilia A","enrollment":66},{"nctId":"NCT01125813","phase":"PHASE3","title":"Efficacy and Safety Study of Human-cl rhFVIII in PTPs With Severe Hemophilia A","status":"COMPLETED","sponsor":"Octapharma","startDate":"2010-06","conditions":"Severe Hemophilia A","enrollment":32}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":17,"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":"Human cl rhFVIII","genericName":"Human cl rhFVIII","companyName":"Octapharma","companyId":"octapharma","modality":"Biologic","firstApprovalDate":"","aiSummary":"Human cl rhFVIII is a recombinant human Factor VIII that replaces deficient or dysfunctional clotting factor VIII to restore blood coagulation in hemophilia A patients. Used for Hemophilia A (congenital Factor VIII deficiency).","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}