{"id":"fxiii-concentrate-human","safety":{"commonSideEffects":[{"rate":null,"effect":"Thrombosis/thromboembolic events"},{"rate":null,"effect":"Hypersensitivity reactions"},{"rate":null,"effect":"Fever"},{"rate":null,"effect":"Headache"}]},"_chembl":{"chemblId":"CHEMBL5315087","moleculeType":"Unknown"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Factor XIII (fibrin-stabilizing factor) is a transglutaminase that cross-links fibrin polymers to strengthen and stabilize blood clots. Patients with FXIII deficiency have impaired clot formation and increased bleeding risk. This concentrate provides exogenous FXIII to restore normal hemostatic function and prevent spontaneous or excessive bleeding.","oneSentence":"FXIII Concentrate replaces deficient coagulation Factor XIII to restore normal blood clot cross-linking and stabilization.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T00:47:06.281Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Congenital Factor XIII deficiency (FXIII deficiency)"},{"name":"Perioperative prophylaxis in Factor XIII-deficient patients"}]},"trialDetails":[{"nctId":"NCT00640289","phase":"NA","title":"Clinical Trial of Factor XIII (FXIII) Concentrate","status":"COMPLETED","sponsor":"Children's Hospital of Orange County","startDate":"2000-01","conditions":"Hemophilia, Factor XIII Deficiency","enrollment":72},{"nctId":"NCT00945906","phase":"PHASE3","title":"An Open Enrollment Study of Factor XIII Concentrate in Subjects With Congenital Factor XIII Deficiency","status":"COMPLETED","sponsor":"CSL Behring","startDate":"2009-09","conditions":"Factor XIII Deficiency","enrollment":61},{"nctId":"NCT00885742","phase":"PHASE3","title":"A Study of Factor XIII Concentrate in Subjects With Congenital Factor XIII Deficiency","status":"COMPLETED","sponsor":"CSL Behring","startDate":"2009-08","conditions":"Factor XIII Deficiency","enrollment":41},{"nctId":"NCT00883090","phase":"PHASE2","title":"A Study of the Use of Factor XIII Concentrate in Patients With Inherited FXIII Deficiency","status":"COMPLETED","sponsor":"CSL Behring","startDate":"2009-05","conditions":"Factor XIII Deficiency","enrollment":15}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":52,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Fibrogammin®-P","Fibrogammin-P"],"phase":"phase_3","status":"active","brandName":"FXIII Concentrate (Human)","genericName":"FXIII Concentrate (Human)","companyName":"CSL Behring","companyId":"csl-behring","modality":"Biologic","firstApprovalDate":"","aiSummary":"FXIII Concentrate replaces deficient coagulation Factor XIII to restore normal blood clot cross-linking and stabilization. Used for Congenital Factor XIII deficiency (FXIII deficiency), Perioperative prophylaxis in Factor XIII-deficient patients.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}