Takeda: Hemophilia B trials

The registry lists 16 Hemophilia B studies with Takeda as lead sponsor. 0 are open to participants now and 9 have results posted.

Phase 1 2Phase 2 3Phase 3 6Phase 4 2No phase 6(a study in two phases counts in both)

Studies

Open to participants first, then studies with results posted, then the rest; newest registration first within each.

• A Phase 1/2 Study of SHP648, an Adeno-Associated Viral Vector for Gene Transfer in Hemophilia B SubjectsTerminatedNCT04394286Phase 1/2Results posted
• RIXUBIS PMS India (RIXUBIS PMS)CompletedNCT03565237Phase 4Results posted
• RIXUBIS Drug Use-Result Survey (Japan)CompletedNCT02937831Results posted
• Recombinant Factor VIIa BI (rFVIIa BI) Treatment of Acute Bleeding Episodes Per an On-demand RegimenCompletedNCT01757405Phase 3Results posted
• BAX 326 Surgery Study in Hemophilia B PatientsCompletedNCT01507896Phase 3Results posted
• BAX 326 Pediatric StudyCompletedNCT01488994Phase 2/3Results posted
• BAX 326 (rFIX) Continuation StudyCompletedNCT01286779Phase 3Results posted
• Pivotal Study (Pharmacokinetics, Efficacy, Safety) of BAX 326 (rFIX) in Hemophilia B PatientsCompletedNCT01174446Phase 3Results posted
• Efficacy and Safety Study of Prophylactic Versus On-Demand Treatment With Feiba NF in Subjects With Hemophilia A or B and a High Titer InhibitorCompletedNCT00851721Phase 3Results posted
• Global Epidemiologic Study of Preexisting Immunity to AAV in Adults With Severe HemophiliaCompletedNCT03185897
• Non-Interventional Study to Capture the Patient Experience on Gene Therapy for Hemophilia Within the AskBio009-101 Study Through Patient and Investigator InterviewsCompletedNCT03054389
• Post-Marketing Surveillance (Usage Results Study) of RIXUBIS in Adult and Pediatric Patients With Haemophilia B in South KoreaCompletedNCT02922231
• Study of Prophylaxis, ACtivity and Effectiveness (SPACE) in Hemophilia Patients Currently Treated With ADVATE or RIXUBISCompletedNCT02190149
• Open-Label Single Ascending Dose of Adeno-associated Virus Serotype 8 Factor IX Gene Therapy in Adults With Hemophilia BActive, not recruitingNCT01687608Phase 1/2
• Osteoporosis and MRI Study in HemophiliaTerminatedNCT01460147Not applicable
• IMMUNINE Pre-Treatment StudyCompletedNCT01128881Phase 4