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Recomb. Factor VIII · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Arm 1 | EXPERIMENTAL | - |
| Arm 2 | EXPERIMENTAL | - |
| Arm 3 | ACTIVE_COMPARATOR | - |
| Arm 4 | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Recomb. Factor VIII (Kogenate FS Liposome, BAY79-4980) | BIOLOGICAL | Low dose of BAY 79-4980 \[13mg of liposomes/kg\] then cross over to rFVIII-FS (35 IU/kg reconstituted in 2.5 mL WFI / 1000 IU). |
| Recombinant Factor VIII (Kogenate FS, BAY14-2222) | BIOLOGICAL | rFVIII-FS (35 IU/kg reconstituted in 2.5mL WFI /1000 IU) then cross over to low dose of BAY 79-4980 \[13mg of liposomes/kg\] |
Inclusion Criteria: * Males aged 12 to 60 years * Hemophilia A with plasma FVIII level less than 1% (severe hemophilia) * No history of FVIII inhibitor antibody formation and no current evidence of inhibitor antibody measured using the Nijmegen modified Bethesda assay (\< 0.6 Nijmegen Bethesda Unit...
Top 8 of 9 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Novo Nordisk A/S Sponsored ADR Class B | NVO | 15 | PHASE3 | Concizumab, Mim8, Denecimig, NNC0442-0344 A, turoctocog alfa pegol |
| Sanofi SA Sponsored ADR | SNY | 5 | PHASE3 | Fitusiran, efanesoctocog alfa |
| Pfizer Inc. | PFE | 8 | PHASE3 | Fidanacogene elaparvovec, Marstacimab |
| BioMarin Pharmaceutical Inc. | BMRN | 2 | PHASE3 | Valoctocogene roxaparvovec |
| Hoffmann-La Roche | RHHBY | 8 | PHASE3 | Emicizumab, NXT007, SPK-8011QQ, SPK-8011, SPK-8016 |
| Regeneron Pharmaceuticals, Inc. | REGN | 2 | PHASE1 | REGV131, LNP1265 |
| Takeda Pharmaceutical Co. Ltd. Sponsored ADR | TAK | 2 | PHASE1 | AskBio009 |
| Bayer | BAYRY | 6 | - | Damoctocog-alfa-pegol |
Recomb. Factor VIII is being developed for the treatment of Hemophilia A, a bleeding disorder. It is an investigational product studied in a Phase 1 clinical trial that evaluated its pharmacokinetics and safety in male patients aged 12 years and older with Hemophilia A.
Recomb. Factor VIII is being developed by Bayer AG, which trades under the ticker BAYRY. The company sponsored the clinical program evaluating this product in Hemophilia A.
Recomb. Factor VIII is in Phase 1 clinical development and is investigational. One Phase 1 trial has been completed, and no active trials are currently listed for this product.
Recomb. Factor VIII has been studied in the Phase 1 trial NCT00629837, titled Pharmacokinetics and Safety of a Single Intravenous Infusion of BAY 79-4980. That trial enrolled 27 participants with Hemophilia A in the United States and has been completed.
Yes. Recomb. Factor VIII is also known as Kogenate FS Liposome and BAY79-4980. These names refer to the same investigational product developed by Bayer AG for Hemophilia A.
The completed Phase 1 trial NCT00629837 was a randomized, double-blind, active-controlled study of a single intravenous infusion of BAY 79-4980. It enrolled 27 male participants aged 12 years and older with Hemophilia A in the United States.