{"id":"recombinant-human-coagulation-fviii","safety":{"commonSideEffects":[{"rate":null,"effect":"Inhibitor development (anti-Factor VIII antibodies)"},{"rate":null,"effect":"Injection site reactions"},{"rate":null,"effect":"Allergic reactions"},{"rate":null,"effect":"Thrombotic events"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Factor VIII is a critical cofactor in the intrinsic coagulation cascade that works with Factor IX to activate Factor X, ultimately leading to thrombin generation and fibrin clot formation. This recombinant product is produced using cell culture technology and is used to treat patients with Factor VIII deficiency or dysfunction. By restoring Factor VIII activity, the drug corrects the bleeding tendency characteristic of hemophilia A.","oneSentence":"Recombinant human coagulation factor VIII replaces deficient or dysfunctional Factor VIII to restore the intrinsic coagulation pathway and enable normal blood clot formation.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T00:04:14.724Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Hemophilia A (Factor VIII deficiency)"},{"name":"Prevention and treatment of bleeding episodes in hemophilia A patients"}]},"trialDetails":[{"nctId":"NCT05936580","phase":"PHASE4","title":"Nuwiq Dosing and Outcomes In the ManagEment of Women/Girls With Haemophilia A Needing FVIII Treatment for Surgery","status":"RECRUITING","sponsor":"Octapharma","startDate":"2026-04","conditions":"Hemophilia A","enrollment":28},{"nctId":"NCT04647227","phase":"PHASE4","title":"SEVENFACT® for Bleeding Events in Hemophilia With Inhibitors","status":"RECRUITING","sponsor":"American Thrombosis and Hemostasis Network","startDate":"2021-06-28","conditions":"Hemophilia A With Inhibitor, Hemophilia B With Inhibitor","enrollment":55},{"nctId":"NCT07129343","phase":"PHASE3","title":"A Study of Recombinant Von Willebrand Factor (rVWF) in Chinese Participants With Von Willebrand Disease (vWD)","status":"RECRUITING","sponsor":"Takeda","startDate":"2025-10-13","conditions":"Von Willebrand Disease (VWD)","enrollment":20},{"nctId":"NCT05036278","phase":"PHASE4","title":"Prophylaxis Regimen for Hemophilia A Patients","status":"COMPLETED","sponsor":"Bayer","startDate":"2022-07-28","conditions":"Hemophilia A, Prophylaxis of Bleeding","enrollment":21},{"nctId":"NCT05935358","phase":"PHASE4","title":"Nuwiq for Perioperative Management Of Patients With Haemophilia A on Emicizumab Regular Prophylaxis Study","status":"RECRUITING","sponsor":"Octapharma","startDate":"2023-11-28","conditions":"Severe Hemophilia A","enrollment":28},{"nctId":"NCT02941783","phase":"","title":"Drug Use Investigation of Kovaltry in Hemophilia A Patients","status":"COMPLETED","sponsor":"Bayer","startDate":"2016-11-30","conditions":"Hemophilia A","enrollment":230},{"nctId":"NCT05582993","phase":"PHASE3","title":"A Study of Vonicog Alfa (rVWF) in Children With Severe Von Willebrand Disease (vWD)","status":"RECRUITING","sponsor":"Takeda","startDate":"2024-11-06","conditions":"Von Willebrand Disease (VWD)","enrollment":24},{"nctId":"NCT04023019","phase":"","title":"Treatment of Hemophilia A Patients With FVIII Inhibitors","status":"RECRUITING","sponsor":"Emory University","startDate":"2020-03-17","conditions":"Hemophilia A","enrollment":120},{"nctId":"NCT03879135","phase":"PHASE3","title":"A Study of Recombinant Von Willebrand Factor (rVWF) in Pediatric and Adult Participants With Severe Von Willebrand Disease (VWD)","status":"COMPLETED","sponsor":"Baxalta now part of Shire","startDate":"2019-04-01","conditions":"Von Willebrand Disease (VWD)","enrollment":38},{"nctId":"NCT02932618","phase":"PHASE3","title":"A Study of Recombinant Von Willebrand Factor (rVWF) With or Without ADVATE in Children With Severe Von Willebrand Disease (VWD)","status":"RECRUITING","sponsor":"Baxalta now part of Shire","startDate":"2017-11-06","conditions":"Von Willebrand Disease","enrollment":31},{"nctId":"NCT04565236","phase":"PHASE4","title":"A Post Approval Commitment Study to Gain More Information on How Safe and Effective KOVALTRY is in Chinese Children, Adolescents /Adults With Severe Hemophilia A","status":"COMPLETED","sponsor":"Bayer","startDate":"2020-09-22","conditions":"Hemophilia A","enrollment":45},{"nctId":"NCT05454774","phase":"EARLY_PHASE1","title":"A Study of FVIII Gene Therapy for Hemophilia A","status":"RECRUITING","sponsor":"Institute of Hematology & Blood Diseases Hospital, China","startDate":"2022-07-19","conditions":"Hemophilia A","enrollment":8},{"nctId":"NCT04046848","phase":"PHASE1, PHASE2","title":"Safety and Pharmacokinetics of Subcutaneous Injection of OCTA101 in Adult Patients With Severe Hemophilia A","status":"TERMINATED","sponsor":"Octapharma","startDate":"2019-07-03","conditions":"Severe Hemophilia A","enrollment":36},{"nctId":"NCT03003533","phase":"PHASE1, PHASE2","title":"A Gene Transfer Study for Hemophilia A","status":"COMPLETED","sponsor":"Spark Therapeutics, Inc.","startDate":"2017-01-26","conditions":"Hemophilia A","enrollment":25},{"nctId":"NCT03344003","phase":"","title":"Immune Tolerance Induction in Haemophilia A Patients Using Wilate or Nuwiq","status":"TERMINATED","sponsor":"Octapharma","startDate":"2018-06-28","conditions":"Hemophilia A","enrollment":14},{"nctId":"NCT06136507","phase":"PHASE3","title":"Study of Efficacy and Safety of FRSW107 in Pediatric Patients With Severe Hemophilia A","status":"NOT_YET_RECRUITING","sponsor":"Jiangsu Gensciences lnc.","startDate":"2026-12-25","conditions":"Severe Hemophilia A","enrollment":76},{"nctId":"NCT02078427","phase":"","title":"ADVATE/ ADYNOVI Hemophilia A Outcome Database (AHEAD)","status":"COMPLETED","sponsor":"Baxalta now part of Shire","startDate":"2011-06-28","conditions":"Hemophilia A","enrollment":951},{"nctId":"NCT06297655","phase":"PHASE3","title":"A Clinical Study of Recombinant Human Coagulation Factor VIII for Injection in Patients With Severe Hemophilia A","status":"NOT_YET_RECRUITING","sponsor":"Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.","startDate":"2024-04","conditions":"Hemophilia A","enrollment":60},{"nctId":"NCT06142552","phase":"PHASE3","title":"Phase 3 Clinical Project of Pegylated Recombinant Human Coagulation Factor VIII-Fc Fusion Protein","status":"RECRUITING","sponsor":"Jiangsu Gensciences lnc.","startDate":"2023-12-27","conditions":"Severe Hemophilia A","enrollment":120},{"nctId":"NCT01561391","phase":"PHASE4","title":"Safety and Efficacy of Activated Recombinant Human Factor VII in Haemophilia Patients With Inhibitors During and After Major Surgery","status":"COMPLETED","sponsor":"Novo Nordisk A/S","startDate":"1998-04","conditions":"Congenital Bleeding Disorder, Haemophilia A With Inhibitors, Haemophilia B With Inhibitors","enrollment":36},{"nctId":"NCT04456387","phase":"PHASE3","title":"An Open Label Study to Determine the Safety and Efficacy of Recombinant Human Coagulation Factor VIII-Fc Fusion Protein for Injection in Adolescent and Adult Patients With Hemophilia A.","status":"COMPLETED","sponsor":"Zhengzhou Gensciences Inc","startDate":"2020-10-15","conditions":"Hemophilia A","enrollment":119},{"nctId":"NCT01311648","phase":"PHASE3","title":"BAY81-8973 Pediatric Safety and Efficacy Trial","status":"COMPLETED","sponsor":"Bayer","startDate":"2011-06-09","conditions":"Haemophilia A","enrollment":94},{"nctId":"NCT06137092","phase":"PHASE3","title":"rFVIII-Fc (Produced by AryoGen Pharmed Co.) Pharmacokinetic Study","status":"COMPLETED","sponsor":"AryoGen Pharmed Co.","startDate":"2023-07-22","conditions":"Severe Hemophilia A","enrollment":50},{"nctId":"NCT02830477","phase":"","title":"Study Evaluating \"Real World\" Treatment Pattern in Previously Treated Hemophilia A Patients Receiving KOVALTRY (Octocog Alfa) for Routine Prophylaxis","status":"COMPLETED","sponsor":"Bayer","startDate":"2016-10-14","conditions":"Hemophilia A, Congenital","enrollment":313},{"nctId":"NCT04864743","phase":"PHASE1","title":"A Study to Evaluate the Pharmacokinetics，Safety and Tolerability of PEG Recombinant Human Coagulation Factor VIII-Fc Fusion Protein for Injection","status":"COMPLETED","sponsor":"Jiangsu Gensciences lnc.","startDate":"2021-06-22","conditions":"Severe Hemophilia A","enrollment":13},{"nctId":"NCT04845399","phase":"PHASE3","title":"Phase III Expansion Trial for Determining the Safety and Efficacy of Recombinant Human Coagulation Factor VIII-Fc Fusion Protein for Injection in Adolescent and Adult Patients With Hemophilia A","status":"COMPLETED","sponsor":"Zhengzhou Gensciences Inc","startDate":"2021-04-16","conditions":"Hemophilia A","enrollment":101},{"nctId":"NCT05251090","phase":"PHASE1","title":"A Study to Evaluate the Safety and Pharmacokinetic of Recombinant Human Coagulation Factor VIII ，Fc Fusion Protein for Injection","status":"COMPLETED","sponsor":"Jiangsu Gensciences lnc.","startDate":"2021-06-16","conditions":"Hemophilia A","enrollment":13},{"nctId":"NCT03006965","phase":"","title":"Pharmacokinetic Characterization of the Hemophilia A Population in Spain Using myPKFiT®","status":"COMPLETED","sponsor":"Spanish Society of Thrombosis and Haemostasis","startDate":"2016-11-11","conditions":"Hemophilia A, Hemophilia, Factor VIII Deficiency","enrollment":50},{"nctId":"NCT05265286","phase":"PHASE2","title":"A Study of Repeat Dosing of PEG Recombinant Human Coagulation Factor VIII-Fc Fusion Protein for Injection","status":"COMPLETED","sponsor":"Jiangsu Gensciences lnc.","startDate":"2022-04-14","conditions":"Severe Hemophilia A","enrollment":15},{"nctId":"NCT02546622","phase":"","title":"ATHN 2: Factor Switching Study","status":"COMPLETED","sponsor":"American Thrombosis and Hemostasis Network","startDate":"2015-09","conditions":"Hemophilia","enrollment":310},{"nctId":"NCT00157105","phase":"PHASE2, PHASE3","title":"Safety and Efficacy Study of a Recombinant and Protein-Free Factor VIII (rAHF-PFM) in Hemophilia A Patients Undergoing Surgery","status":"COMPLETED","sponsor":"Baxalta now part of Shire","startDate":"2001-02-12","conditions":"Hemophilia A","enrollment":59},{"nctId":"NCT02716194","phase":"PHASE1","title":"BAX 826 Dose-Escalation Safety Study","status":"COMPLETED","sponsor":"Baxalta now part of Shire","startDate":"2016-03-03","conditions":"Hemophilia A","enrollment":40},{"nctId":"NCT00916032","phase":"PHASE4","title":"Pharmacokinetic Study of ADVATE 3000 IU in Previously Treated Patients With Severe Hemophilia A","status":"COMPLETED","sponsor":"Baxalta now part of Shire","startDate":"2009-06-29","conditions":"Hemophilia A","enrollment":29},{"nctId":"NCT02170402","phase":"PHASE4","title":"China ADVATE PTP Study","status":"COMPLETED","sponsor":"Baxalta now part of Shire","startDate":"2014-06-26","conditions":"Hemophilia A","enrollment":82},{"nctId":"NCT00157040","phase":"PHASE2, PHASE3","title":"Study of Pharmacokinetics, Efficacy, and Safety of a Recombinant and Protein-Free Factor VIII (rAHF-PFM) in Pediatric Patients With Hemophilia A","status":"COMPLETED","sponsor":"Baxalta now part of Shire","startDate":"2002-06-07","conditions":"Hemophilia A","enrollment":50},{"nctId":"NCT02634723","phase":"","title":"Retrospective Chart Review to Evaluate Safety and Tolerability of ADVATE Among Previously Untreated Patients in China With Moderate to Severe Hemophilia A","status":"COMPLETED","sponsor":"Baxalta now part of Shire","startDate":"2015-12-23","conditions":"Hemophilia A","enrollment":21},{"nctId":"NCT02093741","phase":"","title":"ADVATE 2 mL Post-Authorization Safety Surveillance (PASS)","status":"COMPLETED","sponsor":"Baxalta now part of Shire","startDate":"2013-09-20","conditions":"Hemophilia A, Congenital Factor VIII (FVIII) Deficiency","enrollment":65},{"nctId":"NCT02190149","phase":"","title":"Study of Prophylaxis, ACtivity and Effectiveness (SPACE) in Hemophilia Patients Currently Treated With ADVATE or RIXUBIS","status":"COMPLETED","sponsor":"Baxalta now part of Shire","startDate":"2014-07-22","conditions":"Hemophilia A, Hemophilia B","enrollment":64},{"nctId":"NCT01181128","phase":"PHASE3","title":"Study to Evaluate the Safety, Pharmacokinetics and Efficacy of Recombinant Factor VIII Fc Fusion Protein (rFVIIIFc) in Previously Treated Subjects With Severe Hemophilia A","status":"COMPLETED","sponsor":"Bioverativ Therapeutics Inc.","startDate":"2010-11","conditions":"Severe Hemophilia A","enrollment":165},{"nctId":"NCT01454739","phase":"PHASE3","title":"Long-Term Safety and Efficacy of rFVIIIFc in the Prevention and Treatment of Bleeding Episodes in Previously Treated Participants With Hemophilia A","status":"COMPLETED","sponsor":"Bioverativ Therapeutics Inc.","startDate":"2011-12","conditions":"Hemophilia A","enrollment":240},{"nctId":"NCT01051544","phase":"NA","title":"Study of First TIME Immunotolerance Induction in Severe Hemophilia A Patients With Inhibitor at High Risk of Failure: Comparison With FVIII Concentrates With or Without Von Willebrand Factor - RES.I.S.T. Naive","status":"WITHDRAWN","sponsor":"City of Hope Medical Center","startDate":"2009-09-25","conditions":"Severe Hemophilia A","enrollment":""},{"nctId":"NCT02581969","phase":"","title":"Extension at 10 Years of the: \"Observational Study Evaluating Efficacy and Costs of Secondary Prophylaxis vs On-demand Therapy With Kogenate Bayer in Patients With Severe Haemophilia A.\"","status":"COMPLETED","sponsor":"Bayer","startDate":"2016-04-14","conditions":"Hemophilia A","enrollment":43},{"nctId":"NCT02586012","phase":"PHASE2","title":"Weight-based Dosing in Hemophilia A","status":"TERMINATED","sponsor":"Craig Seaman","startDate":"2015-09","conditions":"Hemophilia","enrollment":30},{"nctId":"NCT01817868","phase":"","title":"Comparison of Efficacy, Safety and Costs of Recombinant FVIII Products Between On-demand and Secondary Prophylaxis Groups in Haemophilia A Patients","status":"COMPLETED","sponsor":"Bayer","startDate":"2013-01-04","conditions":"Hemophilia","enrollment":73},{"nctId":"NCT03747653","phase":"","title":"A Study to Evaluate the Pharmacokinetics of Recombinant Human Coagulation Factor VIII-Fc Fusion Protein for Injection","status":"UNKNOWN","sponsor":"Kaifeng Pharmaceutical (Group) Co., Ltd.","startDate":"2019-03-08","conditions":"Hemophilia A","enrollment":12},{"nctId":"NCT03947567","phase":"PHASE4","title":"Safety and Efficacy of Long-term Treatment With SCT800 in Previously Treated Hemophilia A Patients.","status":"UNKNOWN","sponsor":"Sinocelltech Ltd.","startDate":"2019-07-26","conditions":"Hemophilia A","enrollment":240},{"nctId":"NCT03815318","phase":"PHASE3","title":"Evaluation of SCT800 in Prophylaxis Therapy on Previous Treated Patients With Severe Hemophilia A","status":"COMPLETED","sponsor":"Sinocelltech Ltd.","startDate":"2019-01-21","conditions":"Hemophilia A","enrollment":73},{"nctId":"NCT04061109","phase":"PHASE3","title":"Safety, Efficacy Evaluation of Recombinant Coagulation Factor VIII Injection in Subjects With Hemophilia A.","status":"UNKNOWN","sponsor":"Chia Tai Tianqing Pharmaceutical Group Co., Ltd.","startDate":"2019-05-15","conditions":"Hemophilia A","enrollment":64},{"nctId":"NCT04060836","phase":"PHASE1","title":"Pharmacokinetics Evaluation of Recombinant Coagulation Factor VIII Injection in Subjects With Hemophilia A.","status":"UNKNOWN","sponsor":"Chia Tai Tianqing Pharmaceutical Group Co., Ltd.","startDate":"2019-05-08","conditions":"Hemophilia A","enrollment":24},{"nctId":"NCT03947320","phase":"PHASE3","title":"Safety,Efficacy and Pharmacokinetics Evaluation of SCT800 in Previously Treated Paediatric Patients With Severe Haemophilia A.","status":"UNKNOWN","sponsor":"Sinocelltech Ltd.","startDate":"2019-12-20","conditions":"Hemophilia A","enrollment":70},{"nctId":"NCT02396862","phase":"","title":"Patient Functioning and Well-being, Economic, and Clinical Impact of Hemophilia A and Its Treatment","status":"COMPLETED","sponsor":"Bayer","startDate":"2015-12-09","conditions":"Hemophilia A","enrollment":272},{"nctId":"NCT01184820","phase":"PHASE1","title":"Trial to Evaluate the Pharmacokinetics and Safety Profile of BAY94-9027 Following Single and Multiple Dose Administration","status":"COMPLETED","sponsor":"Bayer","startDate":"2010-10-13","conditions":"Hemophilia A","enrollment":14},{"nctId":"NCT01125813","phase":"PHASE3","title":"Efficacy and Safety Study of Human-cl rhFVIII in PTPs With Severe Hemophilia A","status":"COMPLETED","sponsor":"Octapharma","startDate":"2010-06","conditions":"Severe Hemophilia A","enrollment":32},{"nctId":"NCT02492984","phase":"PHASE4","title":"PF-05208756, Moroctocog Alfa (AF-CC), Xyntha For Hemophilia A","status":"COMPLETED","sponsor":"Pfizer","startDate":"2015-04","conditions":"Hemophilia A","enrollment":85},{"nctId":"NCT01029340","phase":"PHASE3","title":"Trial to Evaluate the Efficacy and Safety of a New Full Length Recombinant Human FVIII for Hemophilia A","status":"COMPLETED","sponsor":"Bayer","startDate":"2009-12","conditions":"Blood Coagulation Disorders, Hemophilia A","enrollment":74},{"nctId":"NCT02921945","phase":"PHASE3","title":"Efficacy and Safety Study of SCT800 for On-demand Treatment With in Patients With Hemophilia A","status":"UNKNOWN","sponsor":"Sinocelltech Ltd.","startDate":"2016-10","conditions":"Hemophilia A","enrollment":50},{"nctId":"NCT02888223","phase":"PHASE1","title":"Pharmacokinetic Study of SCT800 in Previously Treated Patients With Hemophilia A","status":"UNKNOWN","sponsor":"Sinocelltech Ltd.","startDate":"2016-09","conditions":"Hemophilia A","enrollment":16},{"nctId":"NCT01486927","phase":"PHASE2, PHASE3","title":"An Open-label Safety, Efficacy and Pharmacokinetic Study of a Recombinant FVIII Compared to Recombinant Human Antihemophilic FVIII in Patients With Severe Hemophilia A","status":"COMPLETED","sponsor":"CSL Behring","startDate":"2012-02","conditions":"Hemophilia A","enrollment":175},{"nctId":"NCT01790828","phase":"","title":"Post Marketing Surveillance To Observe Safety And Efficacy Of Xyntha® In Subjects With Hemophilia A","status":"COMPLETED","sponsor":"Pfizer","startDate":"2014-02","conditions":"Hemophilia A","enrollment":42},{"nctId":"NCT01436825","phase":"","title":"Validation Study of a cOmputer Pharmacokinetic Tool to assIst in the Follow up Care of haeMophilia A Patients","status":"COMPLETED","sponsor":"Bayer","startDate":"2011-10","conditions":"Haemophilia A","enrollment":69},{"nctId":"NCT01810666","phase":"PHASE4","title":"Prophylaxis Versus on Demand Treatment for Children With Hemophilia A","status":"COMPLETED","sponsor":"Bayer","startDate":"2013-03","conditions":"Hemophilia A","enrollment":30},{"nctId":"NCT00922597","phase":"","title":"Non-interventional Observation of Practical Implementation, Efficacy and Safety of Continuous Infusion With KOGENATE Bayer in Surgery","status":"COMPLETED","sponsor":"Bayer","startDate":"2008-08","conditions":"Hemophilia A","enrollment":26},{"nctId":"NCT00969319","phase":"","title":"Effekt-2 - Efficacy and Safety of Long-term Treatment With KOGENATE® FS in Latin America","status":"COMPLETED","sponsor":"Bayer","startDate":"2009-09","conditions":"Blood Coagulation Disorders, Hemophilia A","enrollment":105},{"nctId":"NCT00629837","phase":"PHASE1","title":"Pharmacokinetics and Safety of a Single Intravenous Infusion of BAY 79-4980","status":"COMPLETED","sponsor":"Bayer","startDate":"2005-09","conditions":"Hemophilia A","enrollment":27},{"nctId":"NCT00623480","phase":"PHASE3","title":"Trial to Evaluate the Effect of Secondary Prophylaxis With rFVIII Therapy in Severe Hemophilia A Adult and/or Adolescent Subjects Compared to That of Episodic Treatment","status":"COMPLETED","sponsor":"Bayer","startDate":"2008-03","conditions":"Hemophilia A","enrollment":84},{"nctId":"NCT02282410","phase":"NA","title":"Evaluate Efficacy and Safety of ADVATE in the Standard Prophylaxis Treatment of Severe or Moderately Severe Hemophilia A","status":"UNKNOWN","sponsor":"The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School","startDate":"2014-12","conditions":"Hemophilia A","enrollment":15},{"nctId":"NCT00782470","phase":"","title":"Evaluation of the Reasons and Consequences of Bleeding in Late Teens and Early Adulthood Patients With Severe Hemophilia A","status":"COMPLETED","sponsor":"Bayer","startDate":"2007-12","conditions":"Hematologic Disease, Blood Coagulation Disorders","enrollment":38},{"nctId":"NCT02280265","phase":"NA","title":"Efficacy and Safety of ADVATE Standard Prophylaxis to Hemophilia A","status":"UNKNOWN","sponsor":"Nanjing Medical University","startDate":"2014-11","conditions":"Hemophilia A","enrollment":15},{"nctId":"NCT01386268","phase":"","title":"Kogenate FS Regulatory Post-Marketing Surveillance","status":"COMPLETED","sponsor":"Bayer","startDate":"2011-06","conditions":"Hemophilia A","enrollment":64},{"nctId":"NCT00874926","phase":"","title":"EFFEKT - Efficacy and Safety of Long-term Treatment With KOGENATE Bayer/FS","status":"COMPLETED","sponsor":"Bayer","startDate":"2008-06","conditions":"Hemophilia A","enrollment":405},{"nctId":"NCT01653639","phase":"PHASE1","title":"Comparative Pharmacokinetic Study of Two Different Strengths of BAY14-2222","status":"COMPLETED","sponsor":"Bayer","startDate":"2012-07","conditions":"Hemophilia A","enrollment":18},{"nctId":"NCT00932555","phase":"","title":"EffeKt Taiwan- Efficacy and Safety of Long-term Treatment With KOGENATE® FS in Taiwan","status":"COMPLETED","sponsor":"Bayer","startDate":"2009-04","conditions":"Hemophilia A","enrollment":82},{"nctId":"NCT01159587","phase":"","title":"Prophylaxis Versus On-demand Therapy Through Economic Report","status":"COMPLETED","sponsor":"Bayer","startDate":"2004-07","conditions":"Hemophilia A","enrollment":58},{"nctId":"NCT00038935","phase":"PHASE3","title":"Study Evaluating BDDRFVIII and ReFacto AF in Hemophilia A","status":"COMPLETED","sponsor":"Wyeth is now a wholly owned subsidiary of Pfizer","startDate":"","conditions":"Hemophilia A","enrollment":""},{"nctId":"NCT00245245","phase":"PHASE2","title":"Study of Recombinant Porcine Factor VIII (FVIII) in Hemophilia and Inhibitors to FVIII","status":"COMPLETED","sponsor":"Octagen Corporation","startDate":"2005-05","conditions":"Hemophilia A","enrollment":12}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":13,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["SCT800"],"phase":"marketed","status":"active","brandName":"Recombinant Human Coagulation FVIII","genericName":"Recombinant Human Coagulation FVIII","companyName":"Sinocelltech Ltd.","companyId":"sinocelltech-ltd","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Recombinant human coagulation factor VIII replaces deficient or dysfunctional Factor VIII to restore the intrinsic coagulation pathway and enable normal blood clot formation. Used for Hemophilia A (Factor VIII deficiency), Prevention and treatment of bleeding episodes in hemophilia A patients.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":3,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}