{"id":"prothrombin-complex-concentrate-human","safety":{"commonSideEffects":[{"rate":null,"effect":"Thromboembolism (venous thromboembolism, myocardial infarction, stroke)"},{"rate":null,"effect":"Allergic reactions / hypersensitivity"},{"rate":null,"effect":"Fever"},{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Nausea"}]},"_chembl":{"chemblId":"CHEMBL6068614","moleculeType":"Protein"},"_dailymed":{"setId":"68fa4f90-8b01-6498-4140-e0be5247c3fe","title":"BALFAXAR (PROTHROMBIN COMPLEX CONCENTRATE (HUMAN)) POWDER, FOR SOLUTION [OCTAPHARMA USA INC]"},"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"PCC is a pooled plasma-derived product containing the vitamin K-dependent factors II, VII, IX, and X (4-factor PCC) or factors II, VII, IX, X plus proteins C and S (enhanced formulations). It rapidly restores these factors in patients with deficiency due to warfarin overdose, liver disease, or disseminated intravascular coagulation, thereby correcting the prolonged prothrombin time and restoring hemostatic capacity.","oneSentence":"Prothrombin Complex Concentrate replaces deficient vitamin K-dependent clotting factors (II, VII, IX, X) to restore coagulation cascade function and reverse anticoagulation.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T00:03:08.221Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Reversal of warfarin-induced anticoagulation in acute bleeding"},{"name":"Correction of vitamin K-dependent factor deficiency in liver disease"},{"name":"Management of disseminated intravascular coagulation (DIC)"}]},"trialDetails":[{"nctId":"NCT03569891","phase":"PHASE3","title":"HOPE-B: Trial of AMT-061 in Severe or Moderately Severe Hemophilia B Patients","status":"COMPLETED","sponsor":"CSL 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Antagonist Needing Urgent Surgery or Invasive Procedures","status":"COMPLETED","sponsor":"Octapharma","startDate":"2008-05","conditions":"Reversal of Anticoagulant Treatment","enrollment":200},{"nctId":"NCT05441553","phase":"PHASE1, PHASE2","title":"A Study to Evaluate the Safety and Efficacy of VGB-R04 in Adult Hemophilia B Patients","status":"UNKNOWN","sponsor":"Shanghai Vitalgen BioPharma Co., Ltd.","startDate":"2022-07","conditions":"Hemophilia B","enrollment":26},{"nctId":"NCT02396342","phase":"PHASE1, PHASE2","title":"Trial of AAV5-hFIX in Severe or Moderately Severe Hemophilia B","status":"COMPLETED","sponsor":"CSL Behring","startDate":"2015-06-10","conditions":"Hemophilia B","enrollment":10},{"nctId":"NCT02557672","phase":"PHASE4","title":"PCC vs. FFP for Post Cardiopulmonary Bypass Coagulopathy and Bleeding","status":"COMPLETED","sponsor":"Mayo Clinic","startDate":"2016-08","conditions":"Bleeding, Blood Loss, Surgical, Cardiovascular Surgical 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Used for Reversal of warfarin-induced anticoagulation in acute bleeding, Correction of vitamin K-dependent factor deficiency in liver disease, Management of disseminated intravascular coagulation (DIC).","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":2,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}