8 completed, 2 terminated. 10 Phase 4.
| Phase | Trials | Status |
|---|---|---|
| Phase 4 | 10 | Completed 8, Terminated 2 |
Follow F8 protein, human: new trials by email Literature Review of F8 protein, human trials Research Report on F8 protein, human
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 |
|---|---|---|---|---|---|---|
| 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 Recombinant Factor VIII (Kovaltry, BAY81-8973) Treatment Group 1, Recombinant Factor VIII (Kovaltry, BAY81-8973) Treatment Group 2, Recombinant Factor VIII (Kovaltry, BAY81-8973) Treatment Group 3 - Hemophilia A | Phase 4 | Completed | Bayer | 45 | 2020-09-22 | 2025-04-18 |
| Moroctocog Alfa (AF-CC) for Prophylaxis and Treatment of Bleeding Episodes in Previously Treated Hemophilia A Patients Moroctocog-alfa (AF-CC) - Hemophilia A | Phase 4 | Completed | Pfizer | 50 | 2020-01-25 | 2021-05-03 |
| PF-05208756, Moroctocog Alfa (AF-CC), Xyntha For Hemophilia A Intravenous infusions of Xyntha - Hemophilia A | Phase 4 | Completed | Pfizer | 85 | 2015-04-01 | 2017-04-04 |
| China ADVATE PTP Study Octocog alfa (recombinant human coagulation factor VIII) - Hemophilia A | Phase 4 | Completed | Baxalta now part of Shire | 82 | 2014-06-26 | 2021-05-03 |
| Prophylaxis Versus on Demand Treatment for Children With Hemophilia A Recombinant Factor VIII (Kogenate FS, BAY14-2222) - Hemophilia A | Phase 4 | Completed | Bayer | 30 | 2013-03-01 | 2015-05-19 |
| Pharmacokinetic Study of ADVATE 3000 IU in Previously Treated Patients With Severe Hemophilia A Octocog alfa (recombinant human coagulation factor VIII) [ADVATE] - Hemophilia A | Phase 4 | Completed | Baxalta now part of Shire | 29 | 2009-06-29 | 2021-05-19 |
| Study Evaluating The Safety Of Xyntha In Usual Care Settings Moroctocog alfa(AF-CC), Blood draw for laboratory testing - Hemophilia A | Phase 4 | Terminated | Pfizer | 12 | 2009-02-01 | 2012-01-20 |
| Russian Kogenate Pediatric Study rFVIII-FS (Kogenate FS, BAY14-2222) 70 IU/kg, dosing once per week, rFVIII-FS (Kogenate FS, BAY14-2222), 70 IU/kg twice per week (30 IU/kg + 40 IU/kg), rFVIII-FS (Kogenate FS, BAY14-2222) 75 IU/kg, dosing three times per week (3 x 25 IU/kg) - Hemophilia A | Phase 4 | Completed | Bayer | 32 | 2007-06-01 | 2015-07-01 |
| Assessment of the Risk of Inhibitor Formation in Previously Treated Patients With Severe Hemophilia A Kogenate (BAY 14-2222) - Hemophilia A | Phase 4 | Terminated | Bayer | 1 | 2006-05-01 | 2014-12-18 |
| BAY14-2222 Prophylaxis and Joint Function Improvement (Adults) Kogenate (BAY14-2222) - Hematologic Disease, Hemophilia A | Phase 4 | Completed | Bayer | 20 | 2006-02-01 | 2014-11-03 |
Hemophilia A (10) · Hemostatic Disorders (2) · Hematologic Diseases (1)
Bayer (5) · Pfizer (3) · Baxalta now part of Shire (2)
China (4) · United States (3) · Russia (2) · Bulgaria (1) · France (1) · India (1) · Italy (1) · New Zealand (1) · Spain (1) · United Kingdom (1)
2014 (2), 2005 (1), 2008 (1), 2015 (1)