Pharmacokinetics, Efficacy and Safety Study of IMMUNATE SD (Human Plasma-Derived Coagulation Factor VIII Concentrate) in Hemophilia A Patients

Inclusion Criteria: \- Plasma factor VIII level as follows: for Parts 1 \& 3: Subjects with severe hemophilia A (plasma baseline factor VIII level \<= 1% measured at time of screening) for Part 2: Subjects with severe (plasma baseline factor VIII level \<= 1% measured at time of screening) or moderately severe hemophilia A (plasma baseline factor VIII level \<= 2% measured at time of screening) * Males \>= 12 but \<= 65 years of age * \>= 35 kg body weight * Previously treated with factor VIII concentrate(s) for a minimum of 150 exposure days (as documented in the subject's medical history) * Evidence of a protective titer to HAV and HBV at the time of screening * Immunocompetent as defined by a CD4+ lymphocyte count \>400/mm3 and an absolute neutrophil count (ANC) \>1500 * Signed informed consent obtained from subject or legally authorized representative Exclusion Criteria: * Documented history of inhibitor to factor VIII with a titer \>= 0.8 BU * Current evidence of inhibitor to factor VIII with a titer \>= 0.8 BU, measured at the time of screening * Abnormal renal function (serum creatinine \> 1.5 mg/dL) * HIV-seropositive individuals with any of the following at the time of screening: * CD4+ lymphocyte count \>400/mm3 * AIDS-related complex * symptomatic AIDS Note: HIV-seropositive subjects with an absolute CD4+ lymphocyte count \> 400/mm3 are eligible to participate. HIV-seropositive subjects receiving highly active anti-retroviral therapy (HAART) regimens are eligible for enrollment if they are not excluded by the above criteria * Active hepatic disease (ALT and AST levels \> 5 times the upper limit of normal) * Clinical or laboratory evidence of hepatic cirrhosis including (but not limited to) a recent and persistent INR (international normalized ratio) \> 1.4, the presence of splenomegaly and/or significant spider angiomata on physical exam, and/or a history of esophageal hemorrhage or documented esophageal varices * Known hypersensitivity to IMMUNATE * The subject is currently participating in another investigational drug study, or has participated in any clinical study involving an investigational drug within 30 days of study entry * The subject is currently receiving, or is scheduled to receive during the course of the study, an immunomodulating drug other than anti-retroviral chemotherapy (e.g., a-interferon, steroids at a dose greater than 10 mg/day) * The subject is identified by the investigator as being unable or unwilling to perform study procedures