{"id":"rix-fp","safety":{"commonSideEffects":[{"rate":"null","effect":"Headache"},{"rate":"null","effect":"Nausea"},{"rate":"null","effect":"Injection site reaction"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"groq-llama-8b","explanation":"rIX-FP works by binding to factor VIII, which is a clotting factor that is deficient or defective in patients with hemophilia A. By binding to factor VIII, rIX-FP helps to prevent excessive bleeding in these patients. This is achieved through a process called immune tolerance induction, where the body's immune system is gradually desensitized to factor VIII, allowing for the production of endogenous factor VIII and reducing the need for frequent infusions of factor VIII replacement therapy.","oneSentence":"rIX-FP is a recombinant, humanized monoclonal antibody that targets factor VIII to prevent bleeding in patients with hemophilia A.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T01:32:27.241Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Prevention of bleeding in patients with hemophilia A"}]},"trialDetails":[{"nctId":"NCT06399289","phase":"PHASE3","title":"Recombinant Fusion Protein Linking Coagulation Factor IX With Albumin (rIX-FP) in Chinese Subjects With Hemophilia B Previously Treated With FIX Therapy","status":"ACTIVE_NOT_RECRUITING","sponsor":"CSL Behring","startDate":"2024-07-28","conditions":"Hemophilia B","enrollment":23},{"nctId":"NCT02053792","phase":"PHASE3","title":"A Safety and Efficacy Extension Study of a Recombinant Fusion Protein Linking Coagulation Factor IX With Albumin (rIX-FP) in Patients With Hemophilia B","status":"COMPLETED","sponsor":"CSL Behring","startDate":"2014-02-06","conditions":"Hemophilia B","enrollment":97},{"nctId":"NCT04108260","phase":"PHASE4","title":"The Effectiveness of Recombinant Coagulation Factor IX With Recombinant Albumin (rIX-FP) in Severe Hemophilia B Patients","status":"UNKNOWN","sponsor":"National Taiwan University Hospital","startDate":"2020-04-21","conditions":"Hemophilia","enrollment":5},{"nctId":"NCT01361126","phase":"PHASE1, PHASE2","title":"A Safety and Efficacy Study of a Recombinant Factor IX in Patients With Severe Hemophilia B","status":"COMPLETED","sponsor":"CSL Behring","startDate":"2011-07","conditions":"Hemophilia B","enrollment":17},{"nctId":"NCT01496274","phase":"PHASE2, PHASE3","title":"A Safety and Efficacy Study of a Recombinant Fusion Protein Linking Coagulation Factor IX With Albumin (rIX-FP) in Patients With Hemophilia B","status":"COMPLETED","sponsor":"CSL Behring","startDate":"2012-02","conditions":"Hemophilia B","enrollment":63},{"nctId":"NCT01662531","phase":"PHASE3","title":"A Safety, Efficacy and Pharmacokinetics Study of a Recombinant Fusion Protein Linking Coagulation Factor IX With Albumin (rIX-FP) in Children With Hemophilia B","status":"COMPLETED","sponsor":"CSL Behring","startDate":"2013-01","conditions":"Hemophilia B","enrollment":27},{"nctId":"NCT01233440","phase":"PHASE1","title":"Safety and Pharmacokinetic Study of a Recombinant Coagulation Factor IX Albumin Fusion Protein in Subjects With Hemophilia B","status":"COMPLETED","sponsor":"CSL Behring","startDate":"2010-10","conditions":"Hemophilia B","enrollment":25}],"_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":"rIX-FP","genericName":"rIX-FP","companyName":"CSL Behring","companyId":"csl-behring","modality":"Biologic","firstApprovalDate":"","aiSummary":"rIX-FP is a recombinant, humanized monoclonal antibody that targets factor VIII to prevent bleeding in patients with hemophilia A. Used for Prevention of bleeding in patients with hemophilia A.","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":1,"withResults":1},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}