Novo Nordisk A/S: Hemophilia B trials

The registry lists 54 Hemophilia B studies with Novo Nordisk A/S as lead sponsor. 4 are open to participants now and 12 have results posted.

Phase 1 15Phase 2 5Phase 3 7Phase 4 3No phase 24(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.

• Post-marketing Surveillance (Special Use-results Surveillance) on Treatment With AlhemoEnrolling by invitationNCT06831734
• Post-Marketing Surveillance (All Case Surveillance) on Treatment With Alhemo® in Patients With Haemophilia A or Haemophilia B With InhibitorsEnrolling by invitationNCT06285071
• A Study Following Males With Haemophilia B on Prophylaxis With Refixia/REBINYNEnrolling by invitationNCT03745924
• Adverse Event Data Collection From External Registries on Nonacog Beta PegolEnrolling by invitationNCT03690336
• A Research Study Investigating Nonacog Beta Pegol (N9-GP) for Treatment and Prevention of Bleedings in Chinese People With Haemophilia BCompletedNCT05365217Phase 3Results posted
• A Trial Evaluating the Efficacy and Safety of Prophylactic Administration of Concizumab in Haemophilia A and B Patients With InhibitorsCompletedNCT03196284Phase 2Results posted
• Pharmacogenetic Testing of Saliva Samples From Patients With Five or More Exposure Days to rFVIIa Analogue in the Adept™2 TrialCompletedNCT02541942Phase 2Results posted
• Safety and Efficacy of Nonacog Beta Pegol (N9-GP) in Previously Untreated Patients With Haemophilia BCompletedNCT02141074Phase 3Results posted
• Safety, Efficacy and Pharmacokinetics of NNC-0156-0000-0009 in Previously Treated Children With Haemophilia B.CompletedNCT01467427Phase 3Results posted
• Safety and Efficacy of NNC-0156-0000-0009 After Long-Term Exposure in Patients With Haemophilia B: An Extension to Trials NN7999-3747 and NN7999-3773CompletedNCT01395810Phase 3Results posted
• Efficacy and Safety of NNC 0078-0000-0007 in Patients With Congenital Haemophilia and InhibitorsCompletedNCT01392547Phase 3Results posted
• Efficacy and Safety of NNC-0156-0000-0009 During Surgical Procedures in Subjects With Haemophilia BCompletedNCT01386528Phase 3Results posted
• Safety and Efficacy of NNC-0156-0000-0009 in Haemophilia B PatientsCompletedNCT01333111Phase 3Results posted
• PROPACT: Retrospective Prophylaxis Patient Case CollectionCompletedNCT00882778Results posted
• Observational Registry of NovoSeven® Used as On-demand Treatment of Bleeds in Patients With Haemophilia A and B With InhibitorsCompletedNCT00703911Results posted
• Haemophilia Patients With Inhibitors Being Treated for Acute Joint BleedsCompletedNCT00486278Phase 2Results posted
• Post-marketing Surveillance (Use Result Surveillance) With Refixia®CompletedNCT03875547
• A Study Following People With Haemophilia A and B, With or Without Inhibitors, When on Usual Treatment (Explorer™6)CompletedNCT03741881
• A Study of the Impact of Hemophilia and Its Treatment on Brain Development, Thinking and Behaviour in Children With HemophiliaCompletedNCT03660774
• Awareness, Care, and Treatment In Obesity Management of Patients With Hemophilia (ACTION) to Inform Hemophilia Obesity Patient Empowerment (HOPE)CompletedNCT03430154
• A Trial Comparing Nonacog Beta Pegol (N9-GP) and ALPROLIX® in Patients With Haemophilia BCompletedNCT03075670Phase 1
• Bridging Hemophilia B Experiences, Results and Opportunities Into Solutions (B-HERO-S)CompletedNCT02568202
• To Quantify the Range of Main Psychosocial Factors Affecting Patients and Caregivers in Their Daily LivesCompletedNCT02241694
• Investigating the Bioequivalence of Eptacog Alfa A 6 mg and NovoSeven® in Healthy Male SubjectsWithdrawnNCT02084810Phase 1
• Impact of Pain on Functional Impairment and Quality of Life in Adults With HemophiliaCompletedNCT01988532
• Project to Update the Study of Congenital Haemophilia in SpainCompletedNCT01959555
• A Trial Investigating the Pharmacokinetics and Pharmacodynamics of rFVIIa in Patients With Haemophilia A or B With or Without InhibitorsCompletedNCT01949792Phase 1
• A Long-term Assessment of Physical Activity, Range of Motion, and Functional Status Following Elective Orthopedic Surgery in Hemophilia Patients With InhibitorsCompletedNCT01830712
• Non-Interventional Study of NovoSeven® Used as On-demand Treatment of Bleeds in Patients With Haemophilia A and B With InhibitorsCompletedNCT01586936
• Non-Interventional Study of NovoSeven® Used in Patients With Haemophilia A and B With Inhibitors When Undergoing SurgeryCompletedNCT01579968
• Non-Interventional Study of NovoSeven® Used in Patients With Haemophilia A and B With Inhibitors Under Normal Clinical PracticeCompletedNCT01579955
• Safety and Tolerability of Intravenous Doses of Activated Recombinant Human Factor VII in Healthy VolunteersCompletedNCT01563471Phase 1
• Pharmacokinetics of Single Bolus Dose of NovoSeven® in Paediatric and Adult Patients With Haemophilia A or B in a Non- Bleeding StateCompletedNCT01562587Phase 1
• Intra-subject Variability Following Administrations of Activated Recombinant Human Factor VII in Haemophilia Patients in a Non-bleeding StateCompletedNCT01562457Phase 1
• Prediction of the Efficacy of Activated Recombinant Human Factor VII in Adult Congenital Haemophilia A or B Patients With Inhibitors by Use of ThromboelastographyCompletedNCT01561924Phase 1
• Bioequivalence of NovoSeven® and a NovoSeven® Formulation Stable at Room Temperature in Healthy Male SubjectsCompletedNCT01561417Phase 1
• Safety and Efficacy of Activated Recombinant Human Factor VII in Haemophilia Patients With Inhibitors During and After Major SurgeryCompletedNCT01561391Phase 4
• Investigation of the Pharmacokinetics of NNC172-2021, at Two Different Dose Levels, in Healthy Japanese SubjectsCompletedNCT01555749Phase 1
• Epidemiological Study on Haemophilia Care and Orthopaedic Status in Developing CountriesCompletedNCT01503567
• Survey Evaluating the Psychosocial Effects of Living With HaemophiliaCompletedNCT01322620
• Investigating Safety and Pharmacokinetics of 2 Different Single Doses of NNC128-0000-2011 in Haemophilia A or B PatientsCompletedNCT01288391Phase 1
• Investigating Safety and Pharmacokinetics of NNC 0128-0000-2011 Compared to NNC 0128-0000-2021 in Healthy Male SubjectsCompletedNCT01272206Phase 1
• Observational Study Describing the Usual Clinical Practice Use of NovoSeven® in the Home Treatment of Joint Bleeds in Patients With Haemophilia A or B and InhibitorsCompletedNCT01234545
• Safety of NNC 0172-0000-2021 in Healthy Male Subjects and Subjects With Haemophilia A or BCompletedNCT01228669Phase 1
• Observational Study on Safety of Room Temperature Stable NovoSeven® in Patients With Haemophilia A or BCompletedNCT01220141
• Safety of 40K Pegylated Recombinant Factor IX in Non-Bleeding Patients With Haemophilia BCompletedNCT00956345Phase 1
• A Single Dose Trial Investigating Safety and Local Tolerability of Ascending Doses of Long Acting Activated Recombinant Human Factor VII in Healthy Male VolunteersCompletedNCT00951873Phase 1
• Safety and Efficacy of 3 Different Doses of Long Acting Factor VII in Haemophilia A or B Patients With InhibitorsCompletedNCT00951405Phase 2
• Safety and Mode of Action of a Single Dose and Multiple Doses of Long Acting Activated Recombinant Human Factor VII in Patients With Haemophilia A and BCompletedNCT00922792Phase 1
• Post-marketing Safety Surveillance of NovoSeven® in Patients With Haemophilia and Inhibitors by Means of the UK Haemophilia DatabaseCompletedNCT00853086
• Observational Patient Diary Study of Treatment Doses for Patients With Haemophilia With Inhibitors to Factors VIII and IXCompletedNCT00710619
• High Dose of Activated Recombinant Human Factor VII for Treatment of Mild/Moderate Joint Bleeds in Haemophilia Patients With InhibitorsCompletedNCT00571584Phase 4
• Trial of NovoSeven® in Haemophilia - Joint BleedsCompletedNCT00108797Phase 4
• Efficacy of NovoSeven® in Bleeding Prophylaxis in HemophiliaCompletedNCT00108758Phase 2