{"id":"haemocomplettan-p","safety":{"commonSideEffects":[{"rate":null,"effect":"Thromboembolism (venous thromboembolism, myocardial infarction, stroke)"},{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Nausea"},{"rate":null,"effect":"Fever"},{"rate":null,"effect":"Hypersensitivity reactions"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"This product contains concentrated human clotting factors II, VII, IX, and X (vitamin K-dependent factors) derived from human plasma. It is used to rapidly correct coagulopathy and restore hemostasis in patients with deficiency of these factors due to vitamin K antagonist therapy, liver disease, or other causes of factor deficiency.","oneSentence":"Haemocomplettan® P is a prothrombin complex concentrate (PCC) that replaces deficient vitamin K-dependent clotting factors to restore coagulation capacity.","_ai_confidence":"high"},"_scrapedAt":"2026-03-27T23:31:47.652Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Reversal of vitamin K antagonist (warfarin) anticoagulation in acute bleeding or urgent procedures"},{"name":"Treatment of coagulopathy due to liver disease or factor deficiency"}]},"trialDetails":[{"nctId":"NCT01575756","phase":"PHASE2","title":"Pharmacokinetic, Efficacy, and Safety Study of Octafibrin Compared to Haemocomplettan/Riastap","status":"COMPLETED","sponsor":"Octapharma","startDate":"2013-06","conditions":"Congenital Fibrinogen Deficiency, Afibrinogenemia","enrollment":22},{"nctId":"NCT02427217","phase":"","title":"An Observational Cohort Study of the Safety and Efficacy of Fibrinogen Concentrate, Human (FCH) in Subjects With Congenital Fibrinogen Deficiency","status":"COMPLETED","sponsor":"CSL Behring","startDate":"2015-05-07","conditions":"Congenital Fibrinogen Deficiency","enrollment":22},{"nctId":"NCT02416817","phase":"PHASE4","title":"Strategy of Transfusion in Trauma Patients - STATA Trial","status":"COMPLETED","sponsor":"University of Sao Paulo General Hospital","startDate":"2014-07","conditions":"Wounds and Injuries","enrollment":156},{"nctId":"NCT00496262","phase":"PHASE2","title":"Human Fibrinogen - Pharmacokinetics","status":"COMPLETED","sponsor":"CSL Behring","startDate":"2007-07","conditions":"Fibrinogen Deficiency","enrollment":15},{"nctId":"NCT01124981","phase":"PHASE2, PHASE3","title":"Haemocomplettan® P During Elective Complex Cardiac Surgery","status":"COMPLETED","sponsor":"Isala","startDate":"2011-02","conditions":"Fibrinogen Deficiency in Complex Cardiac Surgery","enrollment":120},{"nctId":"NCT00701142","phase":"PHASE2","title":"Haemocomplettan® P During Aortic Replacement","status":"COMPLETED","sponsor":"CSL Behring","startDate":"2008-06","conditions":"Aortic Aneurysm","enrollment":80}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":14,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["RiaSTAP","Fibrinogen concentrate"],"phase":"marketed","status":"active","brandName":"Haemocomplettan® P","genericName":"Haemocomplettan® P","companyName":"CSL Behring","companyId":"csl-behring","modality":"Biologic","firstApprovalDate":"","aiSummary":"Haemocomplettan® P is a prothrombin complex concentrate (PCC) that replaces deficient vitamin K-dependent clotting factors to restore coagulation capacity. Used for Reversal of vitamin K antagonist (warfarin) anticoagulation in acute bleeding or urgent procedures, Treatment of coagulopathy due to liver disease or factor deficiency.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}