Study of the Efficacy of Human Recombinant Factor VIII (Kogenate FS) Reconstituted in Pegylated Liposomes.

Inclusion Criteria: * Between 18 and 60 years of age * Severe haemophilia A (≤ 1% of baseline Factor VIII activity) * At least 250 treatment cumulative exposure-days (CEDs) to previous products * At least 25 cumulative exposure-days (CEDs) to previous products during one year prior to study start * If HIV positive, CD4 lymphocytes ≥ 400/µl * Subjects on demand treatment, and with a minimum bleeding/treatment pattern of a four episodes per month, evenly distributed within each month, during the three month preceding study start * Subjects who have given their written informed consent. Exclusion Criteria: * Inhibitors or history of inhibitors * History of adverse reactions related to Factor VIII * Platelet count \<90,000 /µl * Subjects on prophylaxis treatment * Subjects with concomitant debilitating disease (e.g. cancer, non-controlled diabetes, heart insufficiency, renal failure) * Subjects with known sensitivity to blood products * Subjects who have participated in another Ethical Committee approved Clinical Trial (including medical device studies) within the past 30 days * Subjects with a weight over 86 kg or below 50 kg * Subjects who do not understand or are not willing to comply with the requirement of the study protocol * Subjects who cannot differentiate a bleeding episode from other causes of joint pain