Hemophilia Inhibitor PUP Study (HIPS)
This is a multinational, multicenter, observational study to evaluate the changes in immunity upon exposure to FVIII in patients with severe hemophilia A previously untreated with factor concentrates. A single source of recombinant FVIII (Advate) will be used and treatment is at the discretion of the investigator. Subjects will be evaluated for 50 days of exposure to FVIII treatment, or three years, whichever comes first. An exposure day is defined as a calendar day during which one or more infusions of FVIII are given.
1. An informed consent, approved by the appropriate IRB/Independent Ethics Committee, has been administered, signed and dated;
2. Subject with severe hemophilia A defined by a baseline FVIII:C <0.01 IU/ml. FVIII activity will be confirmed at the central laboratory. If the confirmatory level is greater than/equal to to 0.01 IU/ml the child must exit the study;
3. Subject weighs 3.5 kg or more at the time of baseline study evaluation.