18 completed, 1 terminated. 6 Phase 3, 5 Phase 1, 1 Phase 2, 1 Phase 4.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 6 | Completed 5, Terminated 1 |
| Phase 1 | 5 | Completed 5 |
| Phase 2 | 1 | Completed 1 |
| Phase 4 | 1 | Completed 1 |
Follow recombinant factor VIII N8: new trials by email Literature Review of recombinant factor VIII N8 trials Research Report on recombinant factor VIII N8
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Study for Turoctocog Alfa Treatment Regimen in Iraqi Haemophilia A Patients Turoctocog alfa - Congenital Bleeding Disorder, Haemophilia A | Completed | Novo Nordisk A/S | 329 | 2024-11-10 | 2026-06-17 | |
| Turoctocog Alfa in Haemophilic Italian Patients: Protection and Engagement in Recreational Activities Turoctocog alfa - Haemophilia A | Completed | Novo Nordisk A/S | 18 | 2021-04-12 | 2023-11-28 | |
| Study Investigating Novoeight®/NovoEight® (Turoctocog Alfa) in Mexican Haemophilia A Patients turoctocog alfa - Congenital Bleeding Disorder, Haemophilia A | Completed | Novo Nordisk A/S | 10 | 2018-06-20 | 2021-11-15 | |
| Evaluation of Safety Following Immune Tolerance Induction Treatment With Turoctocog Alfa in Patients With Haemophilia A Following Inhibitor Development in NN7170-4213 Trial Turoctocog alfa - Haemophilia A | Phase 3 | Terminated | Novo Nordisk A/S | 1 | 2018-06-12 | 2020-07-07 |
| Research Study to Look at Side Effects During Regular Injection With Factor VIII Medicine Named Turoctocog Alfa for a 8 Weeks Period turoctocog alfa - Congenital Bleeding Disorder, Haemophilia A | Phase 4 | Completed | Novo Nordisk A/S | 60 | 2018-03-01 | 2020-04-17 |
| A Trial Evaluating Efficacy and Safety of Prophylactic Administration of Concizumab in Patients With Severe Haemophilia A Without Inhibitors Concizumab, Turoctocog alfa - Haemostasis, Haemophilia A | Phase 2 | Completed | Novo Nordisk A/S | 36 | 2017-08-16 | 2021-11-16 |
| Efficacy and Safety of Turoctocog Alfa for Prophylaxis and Treatment of Bleeding Episodes in Previously Treated Chinese Patients With Haemophilia A turoctocog alfa - Congenital Bleeding Disorder, Haemophilia A | Phase 3 | Completed | Novo Nordisk A/S | 68 | 2016-12-12 | 2020-07-27 |
| Evaluating the Pharmacokinetics of NovoEight® (Turoctocog Alfa) in Relation to BMI in Subjects With Haemophilia A turoctocog alfa - Congenital Bleeding Disorder, Haemophilia A | Phase 1 | Completed | Novo Nordisk A/S | 35 | 2016-10-10 | 2019-01-30 |
| ATHN 2: Factor Switching Study Factor VIII Replacement Products for Hemophilia which were FDA approved after January 1, 2013, Factor IX Replacement Products for Hemophilia which were FDA approved after January 1, 2013 - Hemophilia | Completed | American Thrombosis and Hemostasis Network | 310 | 2015-09-01 | 2021-12-09 | |
| To Investigate Safety and Efficacy of NovoEight® (rFVIII) During Long-term Treatment of Haemophilia A in Japan turoctocog alfa - Congenital Bleeding Disorder, Haemophilia A | Completed | Novo Nordisk A/S | 40 | 2014-08-04 | 2021-11-15 | |
| Safety and Efficacy of Turoctocog Alfa During Long-Term Treatment of Severe and Moderately Severe Haemophilia A turoctocog alfa - Congenital Bleeding Disorder, Haemophilia A | Completed | Novo Nordisk A/S | 69 | 2014-06-05 | 2020-04-27 | |
| Investigation of the Pharmacokinetics of Turoctocog Alfa in Subjects With Haemophilia A turoctocog alfa - Congenital Bleeding Disorder, Haemophilia A | Phase 1 | Completed | Novo Nordisk A/S | 15 | 2012-12-01 | 2017-02-10 |
| Safety and Efficacy of Turoctocog Alfa in Prevention and Treatment of Bleeds in Previously Untreated Children With Haemophilia A turoctocog alfa - Congenital Bleeding Disorder, Haemophilia A | Phase 3 | Completed | Novo Nordisk A/S | 60 | 2012-09-17 | 2020-11-30 |
| A Single Dose Trial of NNC 0155-0000-0004 in Patients With Haemophilia A turoctocog alfa - Congenital Bleeding Disorder, Haemophilia A | Phase 1 | Completed | Novo Nordisk A/S | 4 | 2011-06-01 | 2017-02-10 |
| A Single Dose Trial of Recombinant Factor VIII (N8) in Japanese Subjects With Haemophilia A: An Extension to Trial NN7008-3543 turoctocog alfa - Congenital Bleeding Disorder, Haemophilia A | Phase 1 | Completed | Novo Nordisk A/S | 6 | 2010-11-01 | 2017-02-10 |
| Safety and Efficacy of Turoctocog Alfa in Previously Treated Male Children With Haemophilia A turoctocog alfa - Congenital Bleeding Disorder, Haemophilia A | Phase 3 | Completed | Novo Nordisk A/S | 65 | 2010-06-01 | 2017-03-17 |
| Safety and Efficacy of Turoctocog Alfa (N8) in Prevention and On-demand Treatment of Bleeding Episodes in Subjects With Haemophilia A: An Extension to Trials NN7008-3543, NN7008-3545, NN7008-3600, NN7008-3893 and NN7008-4015 turoctocog alfa - Congenital Bleeding Disorder, Haemophilia A | Phase 3 | Completed | Novo Nordisk A/S | 214 | 2009-10-26 | 2017-07-27 |
| Safety and Efficacy of Turoctocog Alfa in Haemophilia A Subjects turoctocog alfa - Congenital Bleeding Disorder, Haemophilia A | Phase 3 | Completed | Novo Nordisk A/S | 150 | 2009-04-01 | 2017-03-17 |
| Comparison of the Action of Drugs in the Body and Safety of N8 and Advate® in Haemophilia A Subjects Advate®, turoctocog alfa - Congenital Bleeding Disorder, Haemophilia A | Phase 1 | Completed | Novo Nordisk A/S | 23 | 2009-03-01 | 2017-02-10 |
Hemophilia A (19) · Hemorrhage (1) · Thrombosis (1)
Novo Nordisk A/S (18) · American Thrombosis and Hemostasis Network (1)
Germany (8) · Spain (8) · United States (8) · Italy (7) · Japan (7) · Serbia (6) · Turkey (Türkiye) (6) · Malaysia (5) · United Kingdom (5) · Austria (4) · Brazil (4) · Poland (4) · Russia (4) · Switzerland (4) · Taiwan (4)
Ellis J Neufeld, MD, PhD (1) · Janna Journeycake, MD (1)
PMID 25495795, PMID 25273984, PMID 26679394, PMID 21443634, PMID 23647704, PMID 23651313, PMID 25677761, PMID 26058730, PMID 27291066, PMID 31444162, PMID 35290453
2008 (3), 2016 (2), 2009 (1), 2015 (1), 2017 (1)