21 completed, 2 terminated. 4 Phase 4, 3 Phase 1, 3 Phase 3, 1 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 4 | 4 | Completed 3, Terminated 1 |
| Phase 1 | 3 | Completed 3 |
| Phase 3 | 3 | Completed 3 |
| Phase 2 | 1 | Terminated 1 |
Follow BAY 14-2222: new trials by email Literature Review of BAY 14-2222 trials Research Report on BAY 14-2222
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 |
|---|---|---|---|---|---|---|
| Extension at 10 Years of the: "Observational Study Evaluating Efficacy and Costs of Secondary Prophylaxis vs On-demand Therapy With Kogenate Bayer in Patients With Severe Haemophilia A." Recombinant Factor VIII (Kogenate FS, BAY14-2222) - Hemophilia A | Completed | Bayer | 43 | 2016-04-14 | 2020-11-18 | |
| Patient Functioning and Well-being, Economic, and Clinical Impact of Hemophilia A and Its Treatment Available Recombinant, and Human Factor VIII products incl. Kogenate FS (Recombinant Factor VIII, BAY14-2222) - Hemophilia A | Completed | Bayer | 272 | 2015-12-09 | 2019-03-27 | |
| 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 |
| Comparison of Efficacy, Safety and Costs of Recombinant FVIII Products Between On-demand and Secondary Prophylaxis Groups in Haemophilia A Patients Recombinant Factor VIII (Kogenate, BAY14-2222) - Hemophilia | Completed | Bayer | 73 | 2013-01-04 | 2020-05-27 | |
| Comparative Pharmacokinetic Study of Two Different Strengths of BAY14-2222 Recombinant Factor VIII (Kogenate FS, BAY14-2222) - Hemophilia A | Phase 1 | Completed | Bayer | 18 | 2012-07-01 | 2014-01-10 |
| Validation Study of a cOmputer Pharmacokinetic Tool to assIst in the Follow up Care of haeMophilia A Patients Recombinant Factor VIII (Kogenate FS, BAY14-2222) - Haemophilia A | Completed | Bayer | 69 | 2011-10-01 | 2015-08-10 | |
| Kogenate FS Regulatory Post-Marketing Surveillance Recombinant Factor VIII (Kogenate FS, BAY14-2222) - Hemophilia A | Completed | Bayer | 64 | 2011-06-01 | 2014-08-21 | |
| Trial to Evaluate the Pharmacokinetics and Safety Profile of BAY94-9027 Following Single and Multiple Dose Administration BAY94-9027 + Recombinant Factor VIII (Kogenate FS, BAY14-2222), BAY94-9027 + Recombinant Factor VIII (Kogenate FS, BAY14-2222)) - Hemophilia A | Phase 1 | Completed | Bayer | 14 | 2010-10-13 | 2018-09-07 |
| Trial to Evaluate the Efficacy and Safety of a New Full Length Recombinant Human FVIII for Hemophilia A Recombinant Factor VIII (BAY81-8973), Recombinant Factor VIII (Kogenate FS, BAY14-2222) - Blood Coagulation Disorders, Hemophilia A | Phase 3 | Completed | Bayer | 74 | 2009-12-01 | 2016-11-28 |
| Effekt-2 - Efficacy and Safety of Long-term Treatment With KOGENATE® FS in Latin America Recombinant Factor VIII (Kogenate FS, BAY14-2222) - Blood Coagulation Disorders, Hemophilia A | Completed | Bayer | 105 | 2009-09-01 | 2015-01-19 | |
| EffeKt Taiwan- Efficacy and Safety of Long-term Treatment With KOGENATE® FS in Taiwan Recombinant Factor VIII (Kogenate FS, BAY14-2222) - Hemophilia A | Completed | Bayer | 82 | 2009-04-01 | 2012-03-14 | |
| Non-interventional Observation of Practical Implementation, Efficacy and Safety of Continuous Infusion With KOGENATE Bayer in Surgery Recombinant Factor VIII (Kogenate FS, BAY14-2222) - Hemophilia A | Completed | Bayer | 26 | 2008-08-01 | 2015-04-20 | |
| BAY79-4980 Compared to rFVIII-FS in Previously Treated Patients With Severe Hemophilia A rFVIII-FS/pegylated liposomes (BAY79-4980), rFVIII-FS/WFI (BAY14-2222) - Hemophilia A | Phase 2 | Terminated | Bayer | 143 | 2008-06-01 | 2013-07-15 |
| EFFEKT - Efficacy and Safety of Long-term Treatment With KOGENATE Bayer/FS Recombinant Factor VIII (Kogenate FS, BAY14-2222) - Hemophilia A | Completed | Bayer | 405 | 2008-06-01 | 2014-01-29 | |
| Trial to Evaluate the Effect of Secondary Prophylaxis With rFVIII Therapy in Severe Hemophilia A Adult and/or Adolescent Subjects Compared to That of Episodic Treatment Recombinant Factor VIII (Kogenate FS, BAY14-2222) - Hemophilia A | Phase 3 | Completed | Bayer | 84 | 2008-03-01 | 2014-11-17 |
| Evaluation of the Reasons and Consequences of Bleeding in Late Teens and Early Adulthood Patients With Severe Hemophilia A Recombinant Factor VIII (Kogenate, BAY 14-2222) - Hematologic Disease, Blood Coagulation Disorders | Completed | Bayer | 38 | 2007-12-01 | 2014-11-03 | |
| 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 |
| Pharmacokinetics and Safety of a Single Intravenous Infusion of BAY 79-4980 Recomb. Factor VIII (Kogenate FS Liposome, BAY79-4980), Recombinant Factor VIII (Kogenate FS, BAY14-2222) - Hemophilia A | Phase 1 | Completed | Bayer | 27 | 2005-09-01 | 2014-11-18 |
Showing 20 of 23. Sign in to see all of them.
Hemophilia A (22) · Blood Coagulation Disorders (3) · Hematologic Diseases (2) · Hemostatic Disorders (1)
Bayer (23)
United States (9) · Italy (8) · Spain (6) · Germany (5) · United Kingdom (5) · Austria (4) · France (4) · Israel (4) · Argentina (3) · Croatia (3) · Denmark (3) · Netherlands (3) · Romania (3) · Taiwan (3) · Turkey (Türkiye) (3)
PMID 20059562, PMID 23014711, PMID 23528101, PMID 23750875, PMID 24843882, PMID 25855376, PMID 26931631, PMID 27002680, PMID 27339736, PMID 28836341
2014 (2), 2005 (1), 2008 (1), 2009 (1)