{"id":"plasma-derived-fviii-vwf-concentrate","safety":{"commonSideEffects":[{"rate":null,"effect":"Thrombosis"},{"rate":null,"effect":"Inhibitor development (anti-FVIII antibodies)"},{"rate":null,"effect":"Allergic reactions"},{"rate":null,"effect":"Viral transmission risk (historical concern)"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Factor VIII is a critical cofactor in the intrinsic coagulation pathway, and von Willebrand Factor serves as both a carrier protein for FVIII and a mediator of platelet adhesion. By supplying both proteins from pooled human plasma, this concentrate corrects the underlying deficiency and restores normal hemostasis in patients with FVIII/VWF deficiency or dysfunction.","oneSentence":"This plasma-derived concentrate replaces deficient Factor VIII (FVIII) and von Willebrand Factor (VWF) to restore blood clotting ability in patients with hemophilia A or von Willebrand disease.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T00:01:35.869Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Hemophilia A"},{"name":"von Willebrand disease"}]},"trialDetails":[{"nctId":"NCT04953884","phase":"PHASE3","title":"Efficacy, PK, Immunogenicity and Safety of Wilate in Severe Von Willebrand Disease (VWD) Patients <6 Years of Age","status":"COMPLETED","sponsor":"Octapharma","startDate":"2021-09-22","conditions":"Von Willebrand Disease","enrollment":12},{"nctId":"NCT06205095","phase":"PHASE3","title":"A Pilot Crossover Trial of Prophylactic Wilate Compared to Placebo for Heavy Menstrual Bleeding in Patients with VWD","status":"RECRUITING","sponsor":"Unity Health Toronto","startDate":"2024-10-21","conditions":"Von Willebrand Diseases","enrollment":20},{"nctId":"NCT02472665","phase":"PHASE4","title":"Efficacy and Safety of Fanhdi®, a High-purity Von Willebrand Containing FVIII Concentrate, in Pediatric Patients With Von Willebrand Disease","status":"RECRUITING","sponsor":"Grifols Therapeutics LLC","startDate":"2013-12","conditions":"Von Willebrand Disease","enrollment":8},{"nctId":"NCT00816660","phase":"PHASE1","title":"Pharmacokinetic, Safety and Tolerability Study of Recombinant Von Willebrand Factor / Recombinant Factor VIII Complex in Type 3 Von Willebrand Disease","status":"COMPLETED","sponsor":"Baxalta now part of Shire","startDate":"2008-12-01","conditions":"Von Willebrand Disease","enrollment":32},{"nctId":"NCT01051544","phase":"NA","title":"Study of First TIME Immunotolerance Induction in Severe Hemophilia A Patients With Inhibitor at High Risk of Failure: Comparison With FVIII Concentrates With or Without Von Willebrand Factor - RES.I.S.T. Naive","status":"WITHDRAWN","sponsor":"City of Hope Medical Center","startDate":"2009-09-25","conditions":"Severe Hemophilia A","enrollment":""},{"nctId":"NCT01445197","phase":"PHASE3","title":"Study of Biostate for Treatment of Children With Hemophilia A Complicated by Antibody Development","status":"TERMINATED","sponsor":"CSL Behring","startDate":"2012-12","conditions":"Hemophilia A","enrollment":1},{"nctId":"NCT02479087","phase":"PHASE4","title":"Safety/Efficacy Study to Assess Whether FVIII/VWF Concentrate Can Induce Immune Tolerance in Haemophilia A Patients","status":"UNKNOWN","sponsor":"Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico","startDate":"2015-01","conditions":"Hemophilia A","enrollment":20},{"nctId":"NCT00404300","phase":"PHASE3","title":"Optivate in People With Von Willebrand Disease Undergoing Surgery","status":"TERMINATED","sponsor":"Bio Products Laboratory","startDate":"2007-02","conditions":"Von Willebrand Disease","enrollment":25},{"nctId":"NCT00387192","phase":"PHASE3","title":"A Study With OPTIVATE® in People With Von Willebrand Disease","status":"TERMINATED","sponsor":"Bio Products Laboratory","startDate":"2006-11","conditions":"Von Willebrand Disease","enrollment":26}],"_emaApprovals":[],"_faersSignals":[{"count":2,"reaction":"HAEMORRHAGE"},{"count":2,"reaction":"PULMONARY EMBOLISM"},{"count":1,"reaction":"CARDIOMEGALY"},{"count":1,"reaction":"DEVICE RELATED INFECTION"},{"count":1,"reaction":"DRUG INTOLERANCE"},{"count":1,"reaction":"FACTOR VIII INHIBITION"},{"count":1,"reaction":"INFECTION"},{"count":1,"reaction":"PNEUMONIA"},{"count":1,"reaction":"PNEUMOTHORAX"},{"count":1,"reaction":"RIGHT VENTRICULAR FAILURE"}],"_approvalHistory":[],"publicationCount":6,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Emoclot","Fanhdi"],"phase":"marketed","status":"active","brandName":"Plasma-derived FVIII/VWF concentrate","genericName":"Plasma-derived FVIII/VWF concentrate","companyName":"Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico","companyId":"fondazione-irccs-ca-granda-ospedale-maggiore-policlinico","modality":"Small molecule","firstApprovalDate":"","aiSummary":"This plasma-derived concentrate replaces deficient Factor VIII (FVIII) and von Willebrand Factor (VWF) to restore blood clotting ability in patients with hemophilia A or von Willebrand disease. Used for Hemophilia A, von Willebrand disease.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}