{"id":"alphanate","rwe":[],"tags":[],"phase":"discontinued","safety":{"boxedWarnings":[],"safetySignals":[],"drugInteractions":[],"commonSideEffects":[],"contraindications":[],"specialPopulations":{},"discontinuationRates":[],"seriousAdverseEvents":[]},"status":"discontinued","trials":["NCT03095287","NCT01064284","NCT01051076","NCT01051544","NCT00555555","NCT00323856"],"aliases":["Factor VIII/von Willebrand Factor"],"patents":[],"pricing":[],"offLabel":[],"timeline":[],"brandName":"Alphanate","companyId":"grifols-therapeutics-llc","ecosystem":[],"mechanism":{"target":"","novelty":"","modality":"Biologic","drugClass":"","explanation":"","oneSentence":"","technicalDetail":""},"commercial":null,"references":[],"biosimilars":[],"companyName":"Grifols Therapeutics LLC","competitors":[],"dataSources":[{"url":"https://clinicaltrials.gov","name":"ClinicalTrials.gov","fields":["trialDetails","trials"],"retrievedDate":"2026-04-07"}],"genericName":"Alphanate","indications":{"approved":[],"offLabel":[],"pipeline":[]},"labelChanges":[],"relatedDrugs":[],"trialDetails":[{"nctId":"NCT03095287","phase":"Phase 2","title":"A Multicenter Phase 2 Open-Label, Single-Arm, Prospective, Interventional Study of Plasma-Derived Factor VIII/VWF (Alphanate®) in Immune Tolerance Induction Therapy in Subjects With Congenital Hemophi","status":"TERMINATED","sponsor":"Grifols Therapeutics LLC","isPivotal":false,"enrollment":2,"indication":"Hemophilia A, Congenital","completionDate":"2020-09-18"},{"nctId":"NCT01064284","phase":"Phase 4","title":"Inhibitor Development in Previously Untreated Patients (PUPs) or Minimally Blood Component-Treated Patients (MBCTPs) When Exposed to Plasma-derived Von Willebrand Factor-Containing Factor VIII (VWF/FV","status":"COMPLETED","sponsor":"Fondazione Angelo Bianchi Bonomi","isPivotal":false,"enrollment":303,"indication":"Hemophilia A","completionDate":"2015-05"},{"nctId":"NCT01051076","phase":"NA","title":"Immune Tolerance Induction Study in Patients With Severe Type A Haemophilia With Inhibitor After Failure of a Previous Induction of Immune Tolerance With FVII Concentrates Without Von Willebrand Facto","status":"COMPLETED","sponsor":"City of Hope Medical Center","isPivotal":false,"enrollment":3,"indication":"Severe Hemophilia A","completionDate":"2020-10-21"},{"nctId":"NCT01051544","phase":"NA","title":"Randomised Study of First TIME Immunotolerance Induction in Patients With Severe Type A Haemophilia With Inhibitor at High Risk of Failure: Comparison of Induction of Immune Tolerance With FVIII Conce","status":"WITHDRAWN","sponsor":"City of Hope Medical Center","isPivotal":false,"enrollment":0,"indication":"Severe Hemophilia A","completionDate":"2020-06-25"},{"nctId":"NCT00555555","phase":"Phase 4","title":"A Post-marketing Observational Study to Assess the Efficacy and Safety of the FVIII/VWF Complex (Human), Alphanate®, in Preventing Excessive Bleeding During Surgery in Subjects With Congenital Type 3 ","status":"ACTIVE_NOT_RECRUITING","sponsor":"Grifols Biologicals, LLC","isPivotal":false,"enrollment":15,"indication":"Von Willebrand Disease","completionDate":"2029-03"},{"nctId":"NCT00323856","phase":"Phase 4","title":"Phase IV A Study of Immunologic Safety for Alphanate in Previously Treated Patients Diagnosed With Severe Hemophilia A","status":"COMPLETED","sponsor":"Grifols Biologicals, LLC","isPivotal":false,"enrollment":51,"indication":"Severe Hemophilia A","completionDate":"2018-12-14"}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"administration":{"icon":"","route":"","frequency":"","formulation":""},"formularyStatus":[],"apiManufacturers":[],"developmentCodes":[],"ownershipHistory":[],"therapeuticAreas":["Other"],"biosimilarFilings":[],"firstApprovalDate":"","companionDiagnostics":[],"firstApprovalCountry":null,"genericManufacturerList":[],"modality":"Biologic","aiSummary":"","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":1,"withResults":1},"verificationStatus":"partial","dataCompleteness":{"mechanism":false,"indications":false,"safety":false,"trials":true,"score":1}}