Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Bayer
Subjects in prophylactic treatment arms will undergo clinical evaluation at 10 weeks. Those with adequate control of bleeding will undergo randomization to every 5 or 7 day infusion. Those with continued bleeding will remain in treatment arm and have an increase in dose.
Part B-major surgery - optional sub study included to collect information on efficacy of BAY94-9027 in major surgical setting. Due to rarity of surgery in this population, enrollment to this sub-study may be independent of participation in main study.
Age
12–65
Sex
MALE
Healthy volunteers
Not accepted
You may be eligible if
Male; 12-65 years of age
Subjects with severe hemophilia A
Previously treated with factor VIII for a minimum of 150 exposure days
You may not be if
Inhibitors to FVIII (current evidence or history)
Any other inherited or acquired bleeding disorder in addition to Hemophilia A
Platelet count \< 100,000/mm3
Creatinine \> 2x upper limit of normal or AST/ALT (aspartate aminotransferase/alanine aminotransferase) \> 5x upper limit of normal
Clareo Health | A Trial Investigating Safety and Efficacy of Treatment With BAY94-9027 in Severe Hemophilia A
