{"id":"be1116","safety":{"commonSideEffects":[{"rate":null,"effect":"Injection site reactions"},{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Thrombotic events"},{"rate":null,"effect":"Allergic reactions"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"BE1116 combines human serum albumin with recombinant von Willebrand factor to provide sustained hemostatic support in patients with von Willebrand disease. The fusion design aims to improve the pharmacokinetic profile and duration of action compared to plasma-derived VWF products, reducing bleeding episodes and the need for frequent infusions.","oneSentence":"BE1116 is a recombinant human albumin-von Willebrand factor (VWF) fusion protein that replaces or augments deficient VWF function in von Willebrand disease.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:03:54.213Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Von Willebrand disease (prophylaxis and treatment of bleeding episodes)"}]},"trialDetails":[{"nctId":"NCT07094087","phase":"PHASE3","title":"Efficacy and Safety of 4F-PCC (4-Factor Prothrombin Complex Concentrate) in Adult Patients Undergoing Complex Cardiovascular Surgery With Cardiopulmonary Bypass (CPB)","status":"RECRUITING","sponsor":"CSL Behring","startDate":"2025-09-15","conditions":"Complex Cardiovascular Surgery With Cardiopulmonary Bypass","enrollment":200},{"nctId":"NCT05568888","phase":"PHASE3","title":"Evaluation of BE1116 in Patients With Traumatic Injury and Acute Major Bleeding to Improve Survival ( TAP Study )","status":"TERMINATED","sponsor":"CSL Behring","startDate":"2023-03-28","conditions":"Traumatic Injury","enrollment":1366},{"nctId":"NCT02281201","phase":"PHASE3","title":"Study of a Prothrombin Complex Concentrate for Rapid Reversal of Coagulopathy Induced by Vitamin K Antagonists in Japanese Subjects","status":"COMPLETED","sponsor":"CSL Behring","startDate":"2014-10","conditions":"Acute Major Bleeding, Reversal of Coagulopathy","enrollment":11}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":1,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["4-Factor Prothrombin Complex","Kcentra®","Beriplex®","4F-PCC"],"phase":"phase_3","status":"active","brandName":"BE1116","genericName":"BE1116","companyName":"CSL Behring","companyId":"csl-behring","modality":"Small molecule","firstApprovalDate":"","aiSummary":"BE1116 is a recombinant human albumin-von Willebrand factor (VWF) fusion protein that replaces or augments deficient VWF function in von Willebrand disease. Used for Von Willebrand disease (prophylaxis and treatment of bleeding episodes).","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":1,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}