{"id":"alphanate-sd-ht","safety":{"commonSideEffects":[{"rate":null,"effect":"Inhibitor development (alloimmunization to Factor VIII)"},{"rate":null,"effect":"Thrombosis"},{"rate":null,"effect":"Hypersensitivity reactions"},{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Fever"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"This product contains human antihemophilic factor (Factor VIII) derived from pooled human plasma and processed through solvent/detergent viral inactivation. It works by substituting for the missing or deficient Factor VIII, a critical cofactor in the intrinsic coagulation cascade that is essential for the formation of the tenase complex and subsequent thrombin generation. By restoring Factor VIII activity, the drug enables normal blood clot formation in hemophilia A patients.","oneSentence":"Alphanate SD/HT is a plasma-derived Factor VIII concentrate that replaces deficient clotting factor VIII to restore hemostasis in patients with hemophilia A.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T00:27:00.899Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Hemophilia A (congenital Factor VIII deficiency) — treatment and prevention of bleeding episodes"},{"name":"Perioperative management in hemophilia A patients"}]},"trialDetails":[{"nctId":"NCT00323856","phase":"PHASE4","title":"Safety Study of Alphanate in Previously Treated Patients With Severe Hemophilia A","status":"COMPLETED","sponsor":"Grifols Biologicals, LLC","startDate":"2003-04-08","conditions":"Severe Hemophilia A","enrollment":51},{"nctId":"NCT00555555","phase":"PHASE4","title":"Efficacy of Alphanate FVIII/VWF Concentrate in Type 3 Von Willebrand Patients","status":"ACTIVE_NOT_RECRUITING","sponsor":"Grifols Biologicals, LLC","startDate":"2007-09","conditions":"Von Willebrand Disease","enrollment":15}],"_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":["Anti-hemophilic (human) coagulation factor VIII","Alphanate® Factor VIII/VWF concentrate (Human)"],"phase":"marketed","status":"active","brandName":"Alphanate SD/HT","genericName":"Alphanate SD/HT","companyName":"Grifols Biologicals, LLC","companyId":"grifols-biologicals-llc","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Alphanate SD/HT is a plasma-derived Factor VIII concentrate that replaces deficient clotting factor VIII to restore hemostasis in patients with hemophilia A. Used for Hemophilia A (congenital Factor VIII deficiency) — treatment and prevention of bleeding episodes, Perioperative management in hemophilia A patients.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}