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Also known as rFVIII (BAY81-8973) on demand
rFVIII on demand · 1 trial · 1 indication
The annualized number of bleeds experienced by participants
| Arm | Type | Description |
|---|---|---|
| Arm 1: rFVIII on demand first CS/EP then CS/ADJ | EXPERIMENTAL | Participants received on-demand treatment with recombinant factor VIII (rFVIII, BAY81-8973) assayed by CS/EP (Chromogenic Substrate Assay per European Pharmacopoeia) for 6 months, followed by cross-over to study drug assayed by CS/ADJ (Chromogenic Substrate Assay/label adjusted to one-stage assay) for 6 months. |
| Arm 2: rFVIII on demand first CS/ADJ then CS/EP | EXPERIMENTAL | Participants received on-demand treatment with rFVIII (BAY81-8973) assayed by CS/ADJ for 6 months, followed by cross-over to study drug assayed by CS/EP for 6 months. |
| Arm 3: rFVIII prophylaxis low-dose first CS/EP then CS/ADJ | EXPERIMENTAL | Participants received low dose prophylaxis treatment at 20, 25 or 30 IU/kg twice per week with rFVIII(BAY81-8973) measured by CS/ EP for 6 months then crossed over to study drug measured by CS/ADJ for 6 months. |
| Arm 4: rFVIII prophylaxis low-dose first CS/ADJ then CS/EP | EXPERIMENTAL | Participants received low dose prophylaxis treatment at 20, 25 or 30 IU/kg twice per week with rFVIII (BAY81-8973) measured by CS/ADJ for 6 months then crossed over to study drug measured by CS/ EP for 6 months. |
| Arm 5: rFVIII prophylaxis high-dose first CS/EP then CS/ADJ | EXPERIMENTAL | Participants received high dose prophylaxis treatment at 30, 35 or 40 IU/kg 3 times per week with rFVIII (BAY81-8973) measured by CS/ EP for 6 months then crossed over to study drug measured by CS/ADJ for 6 months. |
| Arm 6: rFVIII prophylaxis high-dose first CS/ADJ then CS/EP | EXPERIMENTAL | Participants received high dose prophylaxis treatment at 30, 35 or 40 IU/kg 3 times per week with rFVIII(BAY81-8973) measured by CS/ADJ for 6 months then crossed over to study drug measured by CS/ EP for 6 months. |
| Name | Type | Description |
|---|---|---|
| rFVIII (BAY81-8973) on demand | BIOLOGICAL | Participants received on-demand treatment with rFVIII (BAY81-8973) assayed by CS/EP (Chromogenic Substrate Assay per European Pharmacopoeia) for 6 months and by CS/ADJ (Chromogenic Substrate Assay/label adjusted to one-stage assay) for 6 months, sequence according to randomization |
| rFVIII (BAY81-8973) prophylaxis low-dose | BIOLOGICAL | Participants received low dose prophylaxis treatment at 20, 25 or 30 IU/kg twice per week with rFVIII (BAY81-8973) assayed by CS/EP for 6 months and by CS/ADJ for 6 months, sequence according to randomization. |
| rFVIII (BAY81-8973) prophylaxis high-dose | BIOLOGICAL | Participants received high dose prophylaxis treatment at 30, 35 or 40 IU/kg 3 times per week with rFVIII (BAY81-8973) assayed by CS/EP for 6 months and by CS/ADJ for 6 months, sequence according to randomization. |
Inclusion Criteria: * Male, aged 12 to 65 years * Severe hemophilia A * History of more than 150 exposure days (ED) with clotting factor concentrates * Currently receiving episodic treatment with FVIII; no regular prophylaxis for more than 6 consecutive months in the past 5 years * No current Facto...
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 |
rFVIII on demand is an on-demand treatment approach for hemophilia A, a bleeding disorder caused by deficient clotting factor VIII. In this regimen, the recombinant factor VIII product is given to treat bleeding episodes as they occur rather than as routine prophylaxis. It was studied in patients with severe hemophilia A.
rFVIII on demand, also known as rFVIII (BAY81-8973) on demand, is developed by Bayer AG, which trades under the ticker BAYRY. Bayer conducted the clinical development of this full length recombinant factor VIII product for hemophilia A.
rFVIII on demand has been studied in Phase 3 clinical development. It is an investigational treatment approach for hemophilia A, and the Phase 3 trial evaluating it has been completed. The program enrolled 80 patients in a randomized, controlled study.
rFVIII on demand was evaluated in the Phase 3 trial NCT01233258, titled A Trial to Compare Prophylaxis Therapy to On-demand Therapy With a New Full Length Recombinant FVIII in Patients With Severe Hemophilia A. The trial is completed and enrolled 80 male patients aged 12 years and older across multiple countries.
Yes, rFVIII on demand is also known as rFVIII (BAY81-8973) on demand. BAY81-8973 is the Bayer development code for this full length recombinant factor VIII product, and the on-demand designation refers to its use for treating bleeding episodes in hemophilia A rather than for routine prophylaxis.
The Phase 3 trial NCT01233258 compared prophylaxis therapy to on-demand therapy with a new full length recombinant factor VIII in patients with severe hemophilia A. It was a randomized, controlled study that enrolled 80 patients, was not double blind, and included male participants aged 12 years and older.