CSL Limited: Hemophilia B trials

The registry lists 16 Hemophilia B studies with CSL Limited as lead sponsor. 4 are open to participants now and 7 have results posted.

Phase 1 3Phase 2 5Phase 3 8No phase 4(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.

• Phase 3, Open-label, Single-dose Study of CSL222 in Adolescent Male Subjects (≥ 12 to < 18 Years of Age) With Severe or Moderately Severe Hemophilia BRecruitingNCT07080905Phase 3
• An Observational Cohort Study to Characterize the Effectiveness and Safety of HEMGENIX® in Patients With Hemophilia BRecruitingNCT06008938
• Efficacy and Safety of CSL222 (Etranacogene Dezaparvovec) Gene Therapy in Adults With Hemophilia B With Pretreatment Adeno-associated Virus Serotype 5 (AAV5) Neutralizing Antibodies (Nabs)RecruitingNCT06003387Phase 3
• Long-term Follow-up Study of Male Adults With Hemophilia B Previously Treated With Etranacogene Dezaparvovec (CSL222)Enrolling by invitationNCT05962398
• HOPE-B: Trial of AMT-061 in Severe or Moderately Severe Hemophilia B PatientsCompletedNCT03569891Phase 3Results posted
• Dose Confirmation Trial of AAV5-hFIXco-PaduaCompletedNCT03489291Phase 2Results posted
• Trial of AAV5-hFIX in Severe or Moderately Severe Hemophilia BCompletedNCT02396342Phase 1/2Results posted
• A Safety and Efficacy Extension Study of a Recombinant Fusion Protein Linking Coagulation Factor IX With Albumin (rIX-FP) in Patients With Hemophilia BCompletedNCT02053792Phase 3Results posted
• A Safety, Efficacy and Pharmacokinetics Study of a Recombinant Fusion Protein Linking Coagulation Factor IX With Albumin (rIX-FP) in Children With Hemophilia BCompletedNCT01662531Phase 3Results posted
• A Safety and Efficacy Study of a Recombinant Fusion Protein Linking Coagulation Factor IX With Albumin (rIX-FP) in Patients With Hemophilia BCompletedNCT01496274Phase 2/3Results posted
• A Safety and Efficacy Study of a Recombinant Factor IX in Patients With Severe Hemophilia BCompletedNCT01361126Phase 1/2Results posted
• Recombinant Fusion Protein Linking Coagulation Factor IX With Albumin (rIX-FP) in Chinese Subjects With Hemophilia B Previously Treated With FIX TherapyCompletedNCT06399289Phase 3
• Study of AAV5-hFIX in Severe or Moderately Severe Haemophilia BCompletedNCT05360706
• Observatory of Patients With Haemophilia B Treated by IdElvion®Active, not recruitingNCT05086575
• Study of Recombinant Factor VIIa Fusion Protein (rVIIa-FP, CSL689) for On-demand Treatment of Bleeding Episodes in Patients With Hemophilia A or B With InhibitorsTerminatedNCT02484638Phase 2/3
• Safety and Pharmacokinetic Study of a Recombinant Coagulation Factor IX Albumin Fusion Protein in Subjects With Hemophilia BCompletedNCT01233440Phase 1