Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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...
rFVIII on demand is a recombinant factor VIII therapy used for the on-demand treatment of bleeding episodes in patients with severe Hemophilia A. It is administered to control bleeding when it occurs, rather than as a preventive prophylaxis regimen.
rFVIII on demand is developed by Bayer AG, a German pharmaceutical company traded on the OTC market under the ticker BAYRY. The company is conducting clinical trials to evaluate this therapy in patients with severe Hemophilia A.
rFVIII on demand is in Phase 3 clinical development. It is an investigational therapy and has not been approved by regulatory authorities. A Phase 3 trial comparing prophylaxis to on-demand therapy has been completed.
rFVIII on demand was evaluated in a completed Phase 3 trial, NCT01233258, which enrolled 80 male patients aged 12 years and older with severe Hemophilia A. The trial compared prophylaxis therapy to on-demand therapy and was conducted across multiple countries including the United States, Argentina, China, and Japan.
rFVIII on demand refers to the on-demand treatment regimen using a new full length recombinant factor VIII. The clinical trial NCT01233258 specifically evaluated this full length recombinant FVIII product when given on-demand, as opposed to prophylactic dosing.