{"id":"higher-volume-c1-esterase-inhibitor","safety":{"commonSideEffects":[{"rate":null,"effect":"Thrombosis / thromboembolic events"},{"rate":null,"effect":"Hypersensitivity reactions"},{"rate":null,"effect":"Infection transmission risk (plasma-derived)"},{"rate":null,"effect":"Headache"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"C1-esterase inhibitor (C1-INH) is a serine protease inhibitor that regulates the initial steps of the contact system (Factor XII, kallikrein) and classical complement pathway. By inhibiting these cascades, it prevents excessive bradykinin generation and complement activation, which are responsible for increased vascular permeability and angioedema. The higher-volume formulation allows for increased dosing or less frequent administration compared to standard C1-INH products.","oneSentence":"A higher-concentration formulation of C1-esterase inhibitor that suppresses activation of the contact system and complement cascade to prevent angioedema attacks.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:42:03.244Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Hereditary angioedema (HAE) with C1-INH deficiency or dysfunction"},{"name":"Acute angioedema attacks in HAE patients"}]},"trialDetails":[{"nctId":"NCT04696146","phase":"PHASE1, PHASE2","title":"Berinert (C1INH) vs Placebo for DGF/IRI","status":"COMPLETED","sponsor":"Cedars-Sinai Medical Center","startDate":"2021-03-03","conditions":"End Stage Renal Disease, Chronic Kidney Diseases","enrollment":45},{"nctId":"NCT01912456","phase":"PHASE3","title":"A Study to Evaluate the Clinical Efficacy and Safety of Subcutaneously Administered C1-esterase Inhibitor in the Prevention of Hereditary Angioedema","status":"COMPLETED","sponsor":"CSL Behring","startDate":"2014-01","conditions":"Hereditary Angioedema Types I and II","enrollment":90},{"nctId":"NCT02134314","phase":"PHASE1, PHASE2","title":"C1INH Inhibitor Preoperative and Post Kidney Transplant to Prevent DGF & IRI","status":"COMPLETED","sponsor":"Cedars-Sinai Medical Center","startDate":"2014-09","conditions":"End Stage Renal Disease, Kidney Failure, Delayed Graft Function","enrollment":70},{"nctId":"NCT01134510","phase":"PHASE1, PHASE2","title":"Safety & Tolerability of Berinert® (C1 Inhibitor) Therapy to Prevent Rejection","status":"COMPLETED","sponsor":"Stanley Jordan, MD","startDate":"2011-08","conditions":"Kidney Transplantation","enrollment":20}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":0,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"phase_3","status":"active","brandName":"Higher-volume C1-esterase inhibitor","genericName":"Higher-volume C1-esterase inhibitor","companyName":"CSL Behring","companyId":"csl-behring","modality":"Biologic","firstApprovalDate":"","aiSummary":"A higher-concentration formulation of C1-esterase inhibitor that suppresses activation of the contact system and complement cascade to prevent angioedema attacks. Used for Hereditary angioedema (HAE) with C1-INH deficiency or dysfunction, Acute angioedema attacks in HAE patients.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}