{"id":"moroctocog-alfa","rwe":[{"pmid":"36467512","year":"2022","title":"Moroctocog Alfa (AF-CC) for Prophylaxis and Treatment of Bleeding Episodes in Previously Treated Patients with Hemophilia A in India.","finding":"","journal":"Indian journal of hematology & blood transfusion : an official journal of Indian Society of Hematology and Blood Transfusion","studyType":"Clinical Study"},{"pmid":"34590394","year":"2021","title":"Monitoring of different factor VIII replacement products using a factor VIII one-stage clotting assay on cobas t 511/711 analysers.","finding":"","journal":"Haemophilia : the official journal of the World Federation of Hemophilia","studyType":"Clinical Study"},{"pmid":"33269010","year":"2020","title":"Safety and Efficacy of Moroctocog Alfa (AF-CC) in Chinese Patients with Hemophilia A: Results of Two Open-Label Studies.","finding":"","journal":"Journal of blood medicine","studyType":"Clinical Study"},{"pmid":"32497363","year":"2020","title":"Impact of treatment regimen with moroctocog alfa (AF-CC) on bleeding rates in paediatric patients with severe haemophilia A.","finding":"","journal":"Haemophilia : the official journal of the World Federation of Hemophilia","studyType":"Clinical Study"},{"pmid":"31883398","year":"2020","title":"Assessing prophylactic use and clinical outcomes in hemophilia A patients treated with rVIII-SingleChain and other common rFVIII products in Germany.","finding":"","journal":"European journal of haematology","studyType":"Clinical Study"}],"tags":[{"label":"Biologic","category":"modality"},{"label":"Active","category":"status"},{"label":"Hereditary factor VIII deficiency disease","category":"indication"},{"label":"Pfizer Ltd","category":"company"}],"phase":"marketed","safety":{},"trials":[],"aliases":[],"company":"Pfizer Ltd","patents":[],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=MOROCTOCOG ALFA","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T00:52:45.175365+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T00:52:56.316659+00:00"},"regulatory.eu":{"url":"","method":"api_direct","source":"European Medicines Agency","rawText":"","confidence":1,"sourceType":"ema_api","retrievedAt":"2026-04-20T00:52:45.194575+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=MOROCTOCOG ALFA","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T00:52:56.939628+00:00"},"mechanism.target_chembl":{"url":"","method":"api_direct","source":"ChEMBL mechanism: Coagulation factor VIII exogenous protein","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T00:52:57.638217+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL2109137/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T00:52:57.544162+00:00"}},"allNames":"refacto af","offLabel":[],"synonyms":["moroctocog alfa","ReFacto AF"],"timeline":[{"date":"1999-04-13","type":"positive","source":"DrugCentral","milestone":"EMA approval (Pfizer Ltd)"}],"approvals":[{"date":"1999-04-13","orphan":false,"company":"Pfizer Ltd","regulator":"EMA"}],"brandName":"Refacto Af","ecosystem":[{"indication":"Hereditary factor VIII deficiency disease","otherDrugs":[{"name":"desmopressin","slug":"desmopressin","company":"Ferring Pharms Inc"},{"name":"emicizumab","slug":"emicizumab","company":"Genentech Inc"},{"name":"vasopressin","slug":"vasopressin","company":"Parke Davis"}],"globalPrevalence":null}],"mechanism":{"modality":"Biologic","explanation":"","oneSentence":"","technicalDetail":"Refacto Af is a recombinant factor VIII protein, which is a glycoprotein that plays a critical role in the coagulation cascade. It is produced through recombinant DNA technology and is designed to mimic the natural factor VIII protein found in the human body."},"commercial":{},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/5166","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=MOROCTOCOG%20ALFA","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=MOROCTOCOG ALFA","fields":["publications"],"source":"PubMed/NCBI"}],"_emaChecked":true,"_enrichedAt":"2026-03-30T12:50:30.296367","_validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T00:52:59.681153+00:00","fieldsConflicting":1,"overallConfidence":0.8},"biosimilars":[],"competitors":[],"genericName":"moroctocog alfa","indications":{"approved":[{"name":"Hereditary factor VIII deficiency disease","source":"DrugCentral","snomedId":28293008,"regulator":"FDA"}],"offLabel":[],"pipeline":[]},"drugCategory":"active","labelChanges":[],"relatedDrugs":[],"trialDetails":[{"nctId":"NCT06940830","phase":"PHASE4","title":"Long-term Study Evaluating Joint Health in People With Haemophilia A Receiving Real-world Prophylactic Treatment With Efanesoctocog Alfa","status":"RECRUITING","sponsor":"Swedish Orphan Biovitrum","startDate":"2025-05-21","conditions":["Hemophilia A"],"enrollment":250,"completionDate":"2028-12"},{"nctId":"NCT04293523","phase":"","title":"A 48-Month Study to Evaluate Long-Term Effectiveness of Elocta on Joint Health","status":"ACTIVE_NOT_RECRUITING","sponsor":"Swedish Orphan Biovitrum","startDate":"2020-03-30","conditions":["Hemophilia A"],"enrollment":427,"completionDate":"2026-07"},{"nctId":"NCT06224907","phase":"PHASE3","title":"Phase 3 Study for Efficacy and Safety Outcomes Data in Japanese Patients With Severe Hemophilia A","status":"ACTIVE_NOT_RECRUITING","sponsor":"BioMarin Pharmaceutical","startDate":"2023-12-25","conditions":["Hemophilia A"],"enrollment":6,"completionDate":"2029-03"},{"nctId":"NCT03588299","phase":"PHASE1,PHASE2","title":"Study to Test the Safety and How Well Patients With Severe Hemophilia A Respond to Treatment With BAY 2599023 (DTX 201), a Drug Therapy That Delivers a Healthy Version of the Defective Factor VIII Gene Into the Nucleus of Liver Cells Using an Altered, Non-infectious Virus (AAV) as a \"Shuttle\"","status":"ACTIVE_NOT_RECRUITING","sponsor":"Bayer","startDate":"2018-11-07","conditions":["Hemophilia A"],"enrollment":11,"completionDate":"2026-11-03"},{"nctId":"NCT07088458","phase":"","title":"An Observational Study to Learn More About How Well Damoctocog Alfa Pegol Works in Previously Treated Children With Hemophilia A","status":"NOT_YET_RECRUITING","sponsor":"Bayer","startDate":"2026-04-30","conditions":["Hemophilia A"],"enrollment":40,"completionDate":"2030-03-01"},{"nctId":"NCT06998524","phase":"PHASE3","title":"A Study to Assess the Efficacy and Safety of Emicizumab in Participants With Type 3 Von Willebrand Disease","status":"RECRUITING","sponsor":"Hoffmann-La Roche","startDate":"2025-06-27","conditions":["Von Willebrand Disease, Type 3"],"enrollment":75,"completionDate":"2029-03-30"},{"nctId":"NCT06883240","phase":"","title":"An Observational Study of Participants With Type 3 Von Willebrand Disease on Prophylactic Standard-of-Care Treatment","status":"RECRUITING","sponsor":"Hoffmann-La Roche","startDate":"2025-04-29","conditions":["Von Willebrand Disease, Type 3"],"enrollment":40,"completionDate":"2026-11-01"},{"nctId":"NCT06111638","phase":"PHASE2,PHASE3","title":"Evaluation of the Safety and Efficacy of Hemophilia A Gene Therapy Drugs","status":"RECRUITING","sponsor":"Shanghai Xinzhi BioMed Co., Ltd.","startDate":"2024-01-03","conditions":["Hemophilia A"],"enrollment":55,"completionDate":"2031-05-30"},{"nctId":"NCT07416526","phase":"PHASE3","title":"A Clinical Study to Evaluate the Effects of NXT007 Compared to Factor VIII Prophylaxis in Participants With Hemophilia A","status":"NOT_YET_RECRUITING","sponsor":"Hoffmann-La Roche","startDate":"2026-05-09","conditions":["Hemophilia A"],"enrollment":126,"completionDate":"2031-09-23"},{"nctId":"NCT07032792","phase":"PHASE2","title":"Factor VIII Inhibitor Bypass Activity (FEIBA) Versus Fresh Frozen Plasma As First Line Therapy For Bleeding After Cardiac Surgery","status":"RECRUITING","sponsor":"Northwell Health","startDate":"2025-11-03","conditions":["Cardiac Disease","Surgery","Bleeding"],"enrollment":140,"completionDate":"2029-11"},{"nctId":"NCT03932201","phase":"","title":"Evaluating Effectiveness and Long Term Safety of Damoctocog Alfa Pegol in Patients, Who Have Been Diagnosed With Hemophilia A","status":"ACTIVE_NOT_RECRUITING","sponsor":"Bayer","startDate":"2019-10-21","conditions":["Hemophilia A"],"enrollment":371,"completionDate":"2027-03-31"},{"nctId":"NCT04461639","phase":"","title":"Study to Learn More About the Safety of Drug Jivi Over a Long Period of Time in Previously Treated Patients With Hemophilia A (Bleeding Disorder Resulting From a Lack of FVIII) Who Are Receiving Jivi Regularly at Their Treating Doctors to Prevent Bleeding","status":"ACTIVE_NOT_RECRUITING","sponsor":"Bayer","startDate":"2021-05-14","conditions":["Hemophilia A"],"enrollment":62,"completionDate":"2028-06-30"},{"nctId":"NCT06349473","phase":"PHASE1","title":"A Study of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SR604 in Two Participants Groups (Part A: Healthy Participants, and Part B: Participants With Hemophilia A or Hemophilia B or Factor VII Deficiency)","status":"RECRUITING","sponsor":"Equilibra Bioscience LLC","startDate":"2024-05-10","conditions":["Healthy Participants","Hemophilia A","Hemophilia B","Factor VII Deficiency"],"enrollment":31,"completionDate":"2026-09-28"},{"nctId":"NCT07446010","phase":"","title":"Post Approval Observational Study to Learn More About How Safe Octocog Alfa is and How Well it Works in Patients With Severe Hemophilia A in India","status":"NOT_YET_RECRUITING","sponsor":"Bayer","startDate":"2026-03-10","conditions":["Severe Hemophilia A"],"enrollment":33,"completionDate":"2026-12-31"},{"nctId":"NCT07439055","phase":"PHASE2,PHASE3","title":"Real-World Joint Outcomes After Selective Transition to Low-Dose Emicizumab in Pediatric Hemophilia A","status":"ACTIVE_NOT_RECRUITING","sponsor":"Chulalongkorn University","startDate":"2025-06-01","conditions":["Hemophilia A Patient"],"enrollment":18,"completionDate":"2026-04-01"},{"nctId":"NCT05568719","phase":"PHASE3","title":"Safety and Effectiveness of Giroctocogene Fitelparvovec or Fidanacogene Elaparvovec in Patients With Hemophilia A or B Respectively","status":"RECRUITING","sponsor":"Pfizer","startDate":"2022-12-28","conditions":["Hemophilia A","Hemophilia B"],"enrollment":173,"completionDate":"2040-02-25"},{"nctId":"NCT04953884","phase":"PHASE3","title":"Efficacy, PK, Immunogenicity and Safety of Wilate in Severe Von Willebrand Disease (VWD) Patients <6 Years of Age","status":"COMPLETED","sponsor":"Octapharma","startDate":"2021-09-22","conditions":["Von Willebrand Disease"],"enrollment":12,"completionDate":"2024-12-16"},{"nctId":"NCT04158934","phase":"","title":"A Long-term Study of ADYNOVI/ADYNOVATE in Participants With Haemophilia A","status":"ACTIVE_NOT_RECRUITING","sponsor":"Baxalta now part of Shire","startDate":"2020-07-09","conditions":["Hemophilia A"],"enrollment":207,"completionDate":"2030-02-28"},{"nctId":"NCT04563520","phase":"PHASE3","title":"SAFE Study: Safety of aPCC Following Emicizumab Prophylaxis","status":"RECRUITING","sponsor":"Emory University","startDate":"2026-03","conditions":["Hemophilia A"],"enrollment":5,"completionDate":"2027-03"},{"nctId":"NCT06579144","phase":"PHASE1","title":"Pharmacokinetic Comparison of Efanesoctocog Alfa vs Other EHL-rFVIII Products in Participants With Severe Haemophilia A","status":"RECRUITING","sponsor":"Swedish Orphan Biovitrum","startDate":"2025-02-24","conditions":["Hemophilia A"],"enrollment":24,"completionDate":"2026-05-28"},{"nctId":"NCT07414511","phase":"","title":"Hemophilia A Research Program","status":"RECRUITING","sponsor":"University of Washington","startDate":"2024-07-31","conditions":["Hemophilia A","Hemophilia A, Severe","Factor VIII (FVIII)","FVIII Deficiency","Carrier of Hemophilia A","Inhibitors","Pregnancy","Maternal Blood Loss","Pregnancy Complications","Bleeding Disorder","Hemorrhage, Postpartum","Alloimmunization","X-Linked"],"enrollment":500,"completionDate":"2029-08"},{"nctId":"NCT05932914","phase":"","title":"Liver Biopsy Following Gene Therapy For Hemophilia","status":"NOT_YET_RECRUITING","sponsor":"St. Jude Children's Research Hospital","startDate":"2026-03","conditions":["Hemophilia A","Hemophilia B"],"enrollment":8,"completionDate":"2030-01"},{"nctId":"NCT06574984","phase":"","title":"Study for Turoctocog Alfa Treatment Regimen in Iraqi Haemophilia A Patients","status":"RECRUITING","sponsor":"Novo Nordisk A/S","startDate":"2024-11-10","conditions":["Congenital Bleeding Disorder","Haemophilia A"],"enrollment":900,"completionDate":"2026-04-30"},{"nctId":"NCT07410130","phase":"","title":"Clinical Spectrum and Management of Von Willebrand Disease Among Children in Assiut Governorate","status":"NOT_YET_RECRUITING","sponsor":"Assiut University","startDate":"2026-03","conditions":["Von Willebrand Disease (VWD)","Inherited Bleeding Disorders in Children","Pediatric Hemostatic Disorders"],"enrollment":25,"completionDate":"2026-12"},{"nctId":"NCT07400848","phase":"","title":"Clinical Laboratory Evaluation, Assessment of Symptoms and Recovery in Patients With Post-COVID-19-Vaccination Syndrome","status":"RECRUITING","sponsor":"University of Bern","startDate":"2026-02-15","conditions":["Post-Acute COVID-19 Vaccination Syndrome","Postviral Fatigue"],"enrollment":200,"completionDate":"2026-11-15"},{"nctId":"NCT05145127","phase":"PHASE3","title":"Open-Label Extension Study of Marstacimab in Hemophilia Participants With or Without Inhibitors","status":"RECRUITING","sponsor":"Pfizer","startDate":"2021-11-17","conditions":["Hemophilia A","Hemophilia B"],"enrollment":245,"completionDate":"2030-07-31"},{"nctId":"NCT05662319","phase":"PHASE3","title":"A Study to Test a Medicine (Fitusiran) Injected Under the Skin for Preventing Bleeding Episodes in Male Adolescent or Adult Participants With Severe Hemophilia","status":"ACTIVE_NOT_RECRUITING","sponsor":"Sanofi","startDate":"2023-02-01","conditions":["Hemophilia"],"enrollment":91,"completionDate":"2029-01-25"},{"nctId":"NCT04431726","phase":"PHASE3","title":"A Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Subcutaneous Emicizumab in Participants From Birth to 12 Months of Age With Hemophilia A Without Inhibitors","status":"ACTIVE_NOT_RECRUITING","sponsor":"Hoffmann-La Roche","startDate":"2021-02-04","conditions":["Severe Hemophilia A"],"enrollment":55,"completionDate":"2030-05-18"},{"nctId":"NCT06716814","phase":"PHASE3","title":"Study to Provide Continued Access to Treatment for Patients Completing a Previous Trial With Efanesoctocog Alfa","status":"RECRUITING","sponsor":"Swedish Orphan Biovitrum","startDate":"2025-03-06","conditions":["Severe Haemophilia A"],"enrollment":104,"completionDate":"2027-03"},{"nctId":"NCT05181618","phase":"PHASE4","title":"A Study to Evaluate Overall Health, Physical Activity, and Joint Outcomes in Participants With Severe or Moderate Hemophilia A Without Factor VIII Inhibitors on Emicizumab Prophylaxis","status":"ACTIVE_NOT_RECRUITING","sponsor":"Hoffmann-La Roche","startDate":"2022-06-20","conditions":["Severe Hemophilia A","Moderate Hemophilia A"],"enrollment":136,"completionDate":"2027-05-21"},{"nctId":"NCT04158648","phase":"PHASE3","title":"A Study to Evaluate the Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of Emicizumab in Participants With Mild or Moderate Hemophilia A Without FVIII Inhibitors","status":"COMPLETED","sponsor":"Hoffmann-La Roche","startDate":"2020-02-10","conditions":["Mild Hereditary Factor VIII Deficiency Disease Without Inhibitor","Moderate Hereditary Factor VIII Deficiency Disease Without Inhibitor","Hemophilia A"],"enrollment":73,"completionDate":"2025-12-19"},{"nctId":"NCT05147662","phase":"PHASE3","title":"A Study to Learn How Safe the Study Treatment BAY94-9027 is and How it Affects the Body in Previously Treated Children Aged 7 to Less Than 12 Years With Severe Hemophilia A, a Genetic Bleeding Disorder That is Caused by the Lack of a Protein Called Clotting Factor 8 (FVIII) in the Blood","status":"COMPLETED","sponsor":"Bayer","startDate":"2022-03-23","conditions":["Treatment of Bleeding","Prophylaxis of Bleeding","Hemophilia A","Children"],"enrollment":36,"completionDate":"2025-06-25"},{"nctId":"NCT06222697","phase":"","title":"A Study to Learn More About the Safety of Damoctocog-alfa-pegol When Used in Routine Medical Care in Korean Participants With Hemophilia A","status":"RECRUITING","sponsor":"Bayer","startDate":"2024-01-24","conditions":["Hemophilia A","Prophylaxis of Bleeding","Treatment of Bleeding"],"enrollment":20,"completionDate":"2028-03-31"},{"nctId":"NCT05022459","phase":"","title":"Prevention of Bleeding in Patients With Moderate and Severe Hemophilia A Playing Sports: A Comparison Between Factor VIII and Emicizumab Prophylaxis","status":"RECRUITING","sponsor":"Wayne State University","startDate":"2023-08-16","conditions":["Hemophilia A"],"enrollment":72,"completionDate":"2029-03"},{"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,"completionDate":"2027-02"},{"nctId":"NCT05768386","phase":"","title":"A Long-Term Follow-Up Study in Severe Hemophilia A Subjects Who Received BMN 270 in a Prior BioMarin Clinical Trial (270-401)","status":"ENROLLING_BY_INVITATION","sponsor":"BioMarin Pharmaceutical","startDate":"2023-01-01","conditions":["Hemophilia A"],"enrollment":172,"completionDate":"2040-01"},{"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,"completionDate":"2027-11-25"},{"nctId":"NCT06738485","phase":"PHASE3","title":"Recombinant Single-chain Factor VIII (rVIII-SingleChain) in Chinese Participants With Hemophilia A Previously Treated With FVIII Products","status":"RECRUITING","sponsor":"CSL Behring","startDate":"2025-01-09","conditions":["Congenital Hemophilia A"],"enrollment":60,"completionDate":"2026-06-26"},{"nctId":"NCT07314983","phase":"","title":"Long-term Anticoagulation in a Patient With Severe Hemophilia A","status":"RECRUITING","sponsor":"University Hospital, Strasbourg, France","startDate":"2025-09-22","conditions":["Hemophilia A"],"enrollment":1,"completionDate":"2026-01-31"},{"nctId":"NCT04204408","phase":"PHASE2","title":"A Research Study Investigating Mim8 in People With Haemophilia A","status":"COMPLETED","sponsor":"Novo Nordisk A/S","startDate":"2020-01-10","conditions":["Healthy Volunteers","Haemophilia A With or Without Inhibitors"],"enrollment":275,"completionDate":"2023-10-06"},{"nctId":"NCT06752850","phase":"PHASE4","title":"A Study to Investigate the Course of Synovial Hypertrophy in Patients With Haemophilia A on Efanesoctocog Alfa Prophylaxis","status":"ACTIVE_NOT_RECRUITING","sponsor":"Swedish Orphan Biovitrum","startDate":"2024-12-19","conditions":["Haemophilia A (Moderate or Severe)","Hemophilia, Classic","Haemophilia","Hemophilia","Classic Hemophilia","Synovial Hypertrophy"],"enrollment":37,"completionDate":"2026-12"},{"nctId":"NCT04146376","phase":"","title":"Von Willebrand Factor in Pregnancy (VIP) Study","status":"RECRUITING","sponsor":"University of Washington","startDate":"2019-10-12","conditions":["Von Willebrand Diseases"],"enrollment":110,"completionDate":"2026-12"},{"nctId":"NCT03754790","phase":"PHASE3","title":"Long-term Safety and Efficacy Study of Fitusiran in Patients With Hemophilia A or B, With or Without Inhibitory Antibodies to Factor VIII or IX","status":"ACTIVE_NOT_RECRUITING","sponsor":"Genzyme, a Sanofi Company","startDate":"2019-01-09","conditions":["Hemophilia"],"enrollment":281,"completionDate":"2026-11-05"},{"nctId":"NCT07265843","phase":"PHASE4","title":"Fibrinogen in Liver Transplant","status":"NOT_YET_RECRUITING","sponsor":"Trauma Hemostatis and Oxygenation Research (THOR) Network","startDate":"2026-01-01","conditions":["Liver Transplant Surgery"],"enrollment":60,"completionDate":"2028-03-01"},{"nctId":"NCT03818763","phase":"PHASE1","title":"Gene Therapy Trial for Platelet Derived Factor VIII Production in Hemophilia A","status":"ACTIVE_NOT_RECRUITING","sponsor":"Medical College of Wisconsin","startDate":"2020-04-29","conditions":["Hemophilia A"],"enrollment":5,"completionDate":"2033-05-01"},{"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,"completionDate":"2024-09-12"},{"nctId":"NCT03587116","phase":"PHASE3","title":"A Study to Evaluate Prospective Efficacy and Safety Data of Current FIX Prophylaxis Replacement Therapy in Adult Hemophilia B Subjects (FIX:C≤2%) or Current FVIII Prophylaxis Replacement Therapy in Adult Hemophilia A Subjects (FVIII:C≤1%)","status":"COMPLETED","sponsor":"Pfizer","startDate":"2018-07-26","conditions":["Hemophilia B","Hemophilia A"],"enrollment":212,"completionDate":"2024-12-13"},{"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,"completionDate":"2026-08"},{"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,"completionDate":"2025-09-16"},{"nctId":"NCT07218185","phase":"","title":"Comparative Effectiveness of INTERCEPT Fibrinogen Complex (IFC) and Cryoprecipitate-AHF (Cryo-AHF) for Treatment of Trauma Associated Hemorrhage","status":"NOT_YET_RECRUITING","sponsor":"Cerus Corporation","startDate":"2026-05","conditions":["Hypofibrinogenemia","Hemorrhage"],"enrollment":320,"completionDate":"2028-08"},{"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,"completionDate":"2030-04-11"},{"nctId":"NCT05817812","phase":"PHASE3","title":"A Study Evaluating Physical Activity and Joint Health in Severe Haemophilia A Patients ≥12 Years Treated Once Weekly With Efanesoctocog Alfa","status":"ACTIVE_NOT_RECRUITING","sponsor":"Swedish Orphan Biovitrum","startDate":"2023-07-31","conditions":["Hemophilia A, Severe"],"enrollment":93,"completionDate":"2026-06-12"},{"nctId":"NCT04323098","phase":"PHASE3","title":"Study to Evaluate the Efficacy and Safety of Valoctocogene Roxaparvovec, With Prophylactic Steroids in Hemophilia A","status":"COMPLETED","sponsor":"BioMarin Pharmaceutical","startDate":"2020-12-08","conditions":["Hemophilia A"],"enrollment":22,"completionDate":"2025-05-08"},{"nctId":"NCT06684314","phase":"","title":"A Study to Evaluate Impact of Efanesoctocog Alfa on Long-term Joint Health in Participants With Hemophilia A in Taiwan","status":"RECRUITING","sponsor":"Sanofi","startDate":"2024-11-11","conditions":["Hemophilia A"],"enrollment":100,"completionDate":"2031-08-28"},{"nctId":"NCT03061201","phase":"PHASE2","title":"A Study of Recombinant AAV2/6 Human Factor 8 Gene Therapy SB-525 (PF-07055480) in Subjects With Severe Hemophilia A","status":"COMPLETED","sponsor":"Pfizer","startDate":"2017-06-21","conditions":["Hemophilia A"],"enrollment":13,"completionDate":"2024-07-16"},{"nctId":"NCT05042440","phase":"PHASE1","title":"Pharmacokinetic Assessment of Standard Half-Life (SHL) FVIII, Extended Half-Life (EHL) FVIII, and Efanesoctocog Alfa (BIVV001) in Severe Hemophilia A","status":"COMPLETED","sponsor":"Sanofi","startDate":"2021-08-11","conditions":["Hemophilia A"],"enrollment":13,"completionDate":"2021-11-24"},{"nctId":"NCT04161495","phase":"PHASE3","title":"A Phase 3 Open-label Interventional Study of Intravenous Recombinant Coagulation Factor VIII Fc-von Willebrand Factor-XTEN Fusion Protein, Efanesoctocog Alfa (BIVV001), in Patients With Severe Hemophilia A","status":"COMPLETED","sponsor":"Bioverativ, a Sanofi company","startDate":"2019-11-19","conditions":["Factor VIII Deficiency"],"enrollment":159,"completionDate":"2022-02-03"},{"nctId":"NCT04759131","phase":"PHASE3","title":"Safety, Efficacy and PK of BIVV001 in Pediatric Patients With Hemophilia A","status":"COMPLETED","sponsor":"Bioverativ, a Sanofi company","startDate":"2021-02-19","conditions":["Hemophilia A"],"enrollment":74,"completionDate":"2023-01-18"},{"nctId":"NCT03370172","phase":"PHASE1,PHASE2","title":"A Study of BAX 888 in Male Adults With Severe Hemophilia A","status":"COMPLETED","sponsor":"Baxalta now part of Shire","startDate":"2018-02-27","conditions":["Hemophilia A"],"enrollment":4,"completionDate":"2024-07-09"},{"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,"completionDate":"2029-06"},{"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,"completionDate":"2025-01-30"},{"nctId":"NCT05643560","phase":"","title":"An Observational Study Called JOIHA to Learn More About How Well the Treatment With Jivi Works to Prevent Problems With Joints in Adults With Hemophilia A.","status":"ACTIVE_NOT_RECRUITING","sponsor":"Bayer","startDate":"2022-12-29","conditions":["Hemophilia A","Prophylaxis of Bleeding"],"enrollment":33,"completionDate":"2027-06-30"},{"nctId":"NCT03520712","phase":"PHASE1,PHASE2","title":"Gene Therapy Study in Severe Hemophilia A Patients With Antibodies Against AAV5","status":"TERMINATED","sponsor":"BioMarin Pharmaceutical","startDate":"2018-04-24","conditions":["Hemophilia A","Gene Therapy","Clotting Disorders","Blood Disorder"],"enrollment":3,"completionDate":"2024-08-07"},{"nctId":"NCT06339567","phase":"NA","title":"Evaluation of the Venous Thrombotic Biological Profile of Different PCOS Phenotypes: French Cross-sectional Study","status":"ACTIVE_NOT_RECRUITING","sponsor":"Fondation Hôpital Saint-Joseph","startDate":"2024-02-08","conditions":["Polycystic Ovary Syndrome"],"enrollment":352,"completionDate":"2029-02-07"},{"nctId":"NCT04370054","phase":"PHASE3","title":"Study to Evaluate the Efficacy and Safety of PF-07055480 / Giroctocogene Fitelparvovec Gene Therapy in Moderately Severe to Severe Hemophilia A Adults","status":"ACTIVE_NOT_RECRUITING","sponsor":"Pfizer","startDate":"2020-08-18","conditions":["Hemophilia A"],"enrollment":77,"completionDate":"2028-10-25"},{"nctId":"NCT06273865","phase":"","title":"Version Testing of EnzySystem Version A for Hemophilia A","status":"SUSPENDED","sponsor":"Radboud University Medical Center","startDate":"2024-05-29","conditions":["Hemophilia A"],"enrollment":40,"completionDate":"2026-05-01"},{"nctId":"NCT05611801","phase":"PHASE3","title":"A Clinical Trial of Study Medicine (Marstacimab) in Pediatric Patients With Hemophilia A or Hemophilia B","status":"RECRUITING","sponsor":"Pfizer","startDate":"2022-12-09","conditions":["Hemophilia A","Hemophilia B"],"enrollment":100,"completionDate":"2028-09-10"},{"nctId":"NCT06550882","phase":"","title":"A Study of OBIZUR in Adults With Acquired Hemophilia A (AHA) in South Korea","status":"RECRUITING","sponsor":"Takeda","startDate":"2025-07-22","conditions":["Acquired Hemophilia A"],"enrollment":9,"completionDate":"2026-09-30"},{"nctId":"NCT06764927","phase":"PHASE4","title":"Fibrinogen in Liver Transplant Subjects","status":"NOT_YET_RECRUITING","sponsor":"Ezeldeen Abuelkasem","startDate":"2025-10-31","conditions":["Liver Transplant Surgery"],"enrollment":30,"completionDate":"2026-03-01"},{"nctId":"NCT04728841","phase":"NA","title":"Gene Therapy for Chinese Hemophilia A","status":"RECRUITING","sponsor":"Institute of Hematology & Blood Diseases Hospital, China","startDate":"2021-03-04","conditions":["Hemophilia A","Gene Therapy"],"enrollment":12,"completionDate":"2028-07-31"},{"nctId":"NCT04644575","phase":"PHASE3","title":"Long-term Safety and Efficacy of Efanesoctocog Alfa (BIVV001) in Previously Treated Patients With Hemophilia A","status":"ACTIVE_NOT_RECRUITING","sponsor":"Bioverativ, a Sanofi company","startDate":"2021-02-23","conditions":["Hemophilia A"],"enrollment":261,"completionDate":"2027-01-15"},{"nctId":"NCT02615691","phase":"PHASE3","title":"A Study of PEGylated Recombinant Factor VIII (BAX855) in Previously Untreated Young Children With Severe Hemophilia A","status":"COMPLETED","sponsor":"Baxalta now part of Shire","startDate":"2015-11-12","conditions":["Hemophilia A"],"enrollment":120,"completionDate":"2024-10-29"},{"nctId":"NCT02740413","phase":"","title":"Treatment Patterns And Outcomes In Patients Treated With Benefix Or Refacto/Refacto AF - A Swedish Cohort Study","status":"COMPLETED","sponsor":"Pfizer","startDate":"2016-01-11","conditions":["Hemophilia A","Hemophilia B"],"enrollment":86,"completionDate":"2017-12-31"},{"nctId":"NCT04684940","phase":"PHASE1,PHASE2","title":"Safety, Tolerability, and Efficacy Study of Valoctocogene Roxaparvovec in Hemophilia A With Active or Prior Inhibitors","status":"ACTIVE_NOT_RECRUITING","sponsor":"BioMarin Pharmaceutical","startDate":"2020-12-10","conditions":["Hemophilia A With Inhibitor","Hemophilia A With Anti Factor VIII"],"enrollment":10,"completionDate":"2029-04"},{"nctId":"NCT05695391","phase":"PHASE3","title":"A Phase 3 Study of the Safety and Efficacy of Coagulation Factor VIIa (Recombinant) for the Prevention of Excessive Bleeding in Patients With Congenital Hemophilia A or B With Inhibitors to Factor VIII or IX Undergoing Elective Major Surgical Procedures SCOPE HIM","status":"TERMINATED","sponsor":"Laboratoire français de Fractionnement et de Biotechnologies","startDate":"2024-06-07","conditions":["Hemophilia"],"enrollment":2,"completionDate":"2025-06-01"},{"nctId":"NCT04091386","phase":"","title":"Study to Learn More About the Physical Activity Level of Patients Suffering From Hemophilia A Treated With Damoctocog Alfa Pegol (LIFE ACTIVE Study)","status":"COMPLETED","sponsor":"Bayer","startDate":"2021-06-10","conditions":["Hemophilia A"],"enrollment":10,"completionDate":"2024-07-05"},{"nctId":"NCT00868530","phase":"PHASE3","title":"Study Evaluating On-Demand Treatment Of Xyntha In Chinese Subjects","status":"COMPLETED","sponsor":"Pfizer","startDate":"2008-09","conditions":["Hemophilia A"],"enrollment":53,"completionDate":"2009-12"},{"nctId":"NCT03938792","phase":"PHASE3","title":"Study of the Efficacy and Safety PF-06741086 in Adult and Teenage Participants With Severe Hemophilia A or Moderately Severe to Severe Hemophilia B","status":"COMPLETED","sponsor":"Pfizer","startDate":"2020-03-09","conditions":["Hemophilia A","Hemophilia B"],"enrollment":189,"completionDate":"2025-04-29"},{"nctId":"NCT05437211","phase":"NA","title":"A Proof-of-concept Study to Reduce Treatment Burden in Haemophilia Participants Receiving Factor VIII and Factor IX Infusions","status":"COMPLETED","sponsor":"Takeda","startDate":"2023-06-23","conditions":["Hemophilia"],"enrollment":24,"completionDate":"2024-02-21"},{"nctId":"NCT05707351","phase":"PHASE3","title":"A Study of Adynovate in Previously Treated Chinese Teenagers and Adults With Severe Hemophilia A","status":"COMPLETED","sponsor":"Takeda","startDate":"2023-03-27","conditions":["Hemophilia A"],"enrollment":37,"completionDate":"2024-09-05"},{"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,"completionDate":"2026-03-31"},{"nctId":"NCT06938659","phase":"PHASE2,PHASE3","title":"Low Dose Emicizumab vs Low Dose Factor VIII in Prophylaxis in Hemophilia A Patients","status":"NOT_YET_RECRUITING","sponsor":"Dhaka Medical College","startDate":"2025-06-01","conditions":["Hemophilia A"],"enrollment":20,"completionDate":"2026-07-31"},{"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,"completionDate":"2024-03-15"},{"nctId":"NCT02576795","phase":"PHASE1,PHASE2","title":"Gene Therapy Study in Severe Haemophilia A Patients (270-201)","status":"COMPLETED","sponsor":"BioMarin Pharmaceutical","startDate":"2015-09-28","conditions":["Severe Haemophilia A"],"enrollment":15,"completionDate":"2024-02-14"},{"nctId":"NCT03370913","phase":"PHASE3","title":"Single-Arm Study To Evaluate The Efficacy and Safety of Valoctocogene Roxaparvovec in Hemophilia A Patients (BMN 270-301)","status":"COMPLETED","sponsor":"BioMarin Pharmaceutical","startDate":"2017-12-19","conditions":["Hemophilia A"],"enrollment":144,"completionDate":"2024-11-20"},{"nctId":"NCT06864975","phase":"PHASE4","title":"Assessing Different FVIII Doses and Frequencies in Immune Tolerance Induction (ITI) with ADVATE Among Hemophilia a Boys with Inhibitor (INITIATE Study)","status":"RECRUITING","sponsor":"Runhui WU","startDate":"2025-03-01","conditions":["Hemophilia a with Inhibitor"],"enrollment":110,"completionDate":"2028-06-21"},{"nctId":"NCT03001830","phase":"PHASE1,PHASE2","title":"Gene Therapy for Haemophilia A.","status":"ACTIVE_NOT_RECRUITING","sponsor":"University College, London","startDate":"2017-06-14","conditions":["Hemophilia A"],"enrollment":14,"completionDate":"2029-12"},{"nctId":"NCT04690322","phase":"PHASE4","title":"POCUS: Hemostatic Potential and Joint Health in Patients With Severe Hemophilia A on Novel Replacement Therapies","status":"RECRUITING","sponsor":"University of Texas Southwestern Medical Center","startDate":"2021-04-15","conditions":["Hemophilia A","Factor VIII"],"enrollment":28,"completionDate":"2027-07"},{"nctId":"NCT05888870","phase":"PHASE4","title":"ITI Using SCT800 Alone or Combining Daratumumab in Hemophilia A Adolescents and Adults With High Titer Inhibitor","status":"RECRUITING","sponsor":"Institute of Hematology & Blood Diseases Hospital, China","startDate":"2023-11-22","conditions":["Hemophilia A With Inhibitor"],"enrollment":50,"completionDate":"2026-12-01"},{"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,"completionDate":"2027-09-15"},{"nctId":"NCT05523128","phase":"NA","title":"The Efficacy and Safety of ZS802 in Chinese Hemophilia A Patients.","status":"RECRUITING","sponsor":"Institute of Hematology & Blood Diseases Hospital, China","startDate":"2022-09-29","conditions":["Hemophilia A"],"enrollment":6,"completionDate":"2025-10"},{"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,"completionDate":"2022-02-18"},{"nctId":"NCT03169972","phase":"","title":"ADYNOVATE Drug Use-Results Survey","status":"COMPLETED","sponsor":"Takeda","startDate":"2017-02-01","conditions":["Hemophilia A"],"enrollment":135,"completionDate":"2023-09-15"},{"nctId":"NCT00323856","phase":"PHASE4","title":"Safety Study of Alphanate in Previously Treated Patients With Severe Hemophilia A","status":"COMPLETED","sponsor":"Grifols Biologicals, LLC","startDate":"2003-04-08","conditions":["Severe Hemophilia A"],"enrollment":51,"completionDate":"2018-12-14"},{"nctId":"NCT04675541","phase":"","title":"Register of Patients With haEmophilia A tReated With Afstyla®","status":"COMPLETED","sponsor":"CSL Behring","startDate":"2018-09-24","conditions":["Haemophilia A"],"enrollment":62,"completionDate":"2024-12-31"},{"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,"completionDate":"2023-12-05"},{"nctId":"NCT02460458","phase":"","title":"Type 3 Von Willebrand International Registries Inhibitor Prospective Study","status":"COMPLETED","sponsor":"Fondazione Angelo Bianchi Bonomi","startDate":"2012-11-05","conditions":["Type 3 Von Willebrand's Disease"],"enrollment":265,"completionDate":"2023-04-17"},{"nctId":"NCT06205095","phase":"PHASE3","title":"A Pilot Crossover Trial of Prophylactic Wilate Compared to Placebo for Heavy Menstrual Bleeding in Patients with VWD","status":"RECRUITING","sponsor":"Unity Health Toronto","startDate":"2024-10-21","conditions":["Von Willebrand Diseases"],"enrollment":20,"completionDate":"2026-09"},{"nctId":"NCT02207894","phase":"","title":"A Survey on the Success of Inhibitor Elimination Using Individualized Concentrate Selection and Controlled ITI","status":"RECRUITING","sponsor":"Haemophilia Centre Rhine Main","startDate":"2006-08","conditions":["Haemophilia A"],"enrollment":300,"completionDate":"2027-12"},{"nctId":"NCT06738901","phase":"PHASE3","title":"An Open-label Study Evaluating the Efficacy, Safety, Pharmacokinetics, and Immunogenicity of SKP-0141 for the Treatment and Prophylaxis in Severe Hemophilia a Patients","status":"NOT_YET_RECRUITING","sponsor":"SK Plasma Co., Ltd.","startDate":"2025-03-31","conditions":["Hemophilia A, Severe"],"enrollment":55,"completionDate":"2026-08-31"}],"_emaApprovals":[{"date":"1999-04-13","status":"Authorised","company":"Pfizer Ltd"}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"crossReferences":{"MMSL":"d00525","NDDF":"002035","UNII":"113E3Z3CJJ","VANDF":"4019616","INN_ID":"7044","RXNORM":"1300485","UMLSCUI":"C0966500","chemblId":"CHEMBL2109137","ChEMBL_ID":"CHEMBL2109137","DRUGBANK_ID":"DB13999","SNOMEDCT_US":"278910002"},"formularyStatus":[],"_enricherVersion":"v2","developmentCodes":[],"ownershipHistory":[{"period":"","companyName":"Pfizer Ltd","relationship":"Original Developer"}],"publicationCount":21,"therapeuticAreas":["Metabolic"],"biosimilarFilings":[],"originalDeveloper":"Pfizer Ltd","recentPublications":[{"date":"2022 Nov 27","pmid":"36467512","title":"Moroctocog Alfa (AF-CC) for Prophylaxis and Treatment of Bleeding Episodes in Previously Treated Patients with Hemophilia A in India.","journal":"Indian journal of hematology & blood transfusion : an official journal of Indian Society of Hematology and Blood Transfusion"},{"date":"2021 Nov","pmid":"34590394","title":"Monitoring of different factor VIII replacement products using a factor VIII one-stage clotting assay on cobas t 511/711 analysers.","journal":"Haemophilia : the official journal of the World Federation of Hemophilia"},{"date":"2020","pmid":"33269010","title":"Safety and Efficacy of Moroctocog Alfa (AF-CC) in Chinese Patients with Hemophilia A: Results of Two Open-Label Studies.","journal":"Journal of blood medicine"},{"date":"2020 Sep","pmid":"32497363","title":"Impact of treatment regimen with moroctocog alfa (AF-CC) on bleeding rates in paediatric patients with severe haemophilia A.","journal":"Haemophilia : the official journal of the World Federation of Hemophilia"},{"date":"2020 Apr","pmid":"31883398","title":"Assessing prophylactic use and clinical outcomes in hemophilia A patients treated with rVIII-SingleChain and other common rFVIII products in Germany.","journal":"European journal of haematology"}],"companionDiagnostics":[],"genericManufacturerList":[],"status":"approved","companyName":"Pfizer Ltd","companyId":"pfizer","modality":"Recombinant protein","firstApprovalDate":"1999","aiSummary":"","enrichmentLevel":3,"visitCount":0,"regulatoryByCountry":[{"country_code":"EU","regulator":"EMA","status":"pending","approval_date":null,"mah":"","brand_name_local":"","application_number":""},{"country_code":"CA","regulator":"Health Canada","status":"approved","approval_date":null,"mah":"","brand_name_local":"","application_number":""},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null}],"trialStats":{"total":0,"withResults":0},"validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T00:52:59.681153+00:00","fieldsConflicting":1,"overallConfidence":0.8},"verificationStatus":"partial","dataCompleteness":{"mechanism":false,"indications":true,"safety":false,"trials":true,"score":2}}