Hemophilia A
Conditions
Interventions
There will be 4 treatment arms:
- An on-demand group
- Twice a week
- Once every 5 days
- Once a week
The trial can be divided in the following phases:
- Screening phase (for all patients)
- pati
Sponsors
Bayer
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: * Male; 12 to 65 years of age (or Male 18-65 years of age in countries where enrollment of minors is not permitted) * Subjects with severe hemophilia A (baseline FVIII activity FVIII:C <1%) determined by measurement at the time of screening or from reliable prior documentation (eg, measurement in other clinical trials, result from approved clinical laboratory) * Previously treated with FVIII concentrate(s) (plasma derived or recombinant) for a minimum of 150 ED * Immunocompetent. If HIV positive, CD4+ lymphocyte count >200/mm3
Exclusion criteria
Exclusion criteria: * Current evidence of inhibitor to FVIII with a titer * 0.6 BU/mL, measured by the Nijmegen modified Bethesda assay at the time of screening (central laboratory) (BU: Bethesda unit) * History of inhibitor to FVIII with a titer * 0.6 BU, or clinical history suggestive of inhibitor requiring modification of treatment. Subjects with a maximum historical titer of 1.0 BU on a single measurement but with at least 3 subsequent successive negative results (< 0.6 BU) thereafter are eligible * Any other inherited or acquired bleeding disorder in addition to Hemophilia A * Platelet count < 100,000/mm3 * Creatinine > 2x upper limit of normal * AST or ALT > 5x upper limit of normal (AST: aspartate aminotransferase; ALT: alanine aminotransferase) * The subject is currently participating in another investigational drug study, or has participated in a clinical study involving an investigational drug within 30 days of study entry. Subjects who are currently participating in an investigational study in which they are treated with a currently marketed FVIII concentrate are not excluded. Subjects currently treated with BAY 81-8973, and who have received at least 100 ED with the investigational product, may continue treatment with the product up to the start of Visit 1. * Any subject who is receiving chemotherapy, immune modulatory drugs other than anti-retroviral chemotherapy, or chronic use of oral or intravenous (IV) corticosteroids within the last 3 months. Brief courses of prednisone/methyprednisolone (< 14 days) for treatment of disorders such as synovitis, asthma, etc are allowed at the discretion of the treating physician.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total number of bleedings as reported by the subjects (efficacy) | — |
Secondary
| Measure | Time frame |
|---|---|
| - questionnaires (evaluate subject*s assessment) - adverse events (safety and tolerability) - pharmacokinetics and incremental recovery following administration of Bay 94-9027 - questionnaires for quality of life, work productivity and pain | — |
Countries
Netherlands
Outcome results
None listed