Safety, Efficacy and Pharmacokinetics of GreenGene™ F to Previously Treated Patients With Severe Hemophilia A

Exclusion Criteria

• •1. Presence at Screening of FVIII inhibitor ≥ 0.6 BU as tested with the Nijmegen modification of the Bethesda assay in either central or local laboratory
• •2. History of FVIII inhibitor of ≥ 0.6 BU as measured using the Nijmegen modification of the Bethesda assay
• •3. History of FVIII inhibitor ≥ 1.0 BU if the subject has been tested routinely using the original Bethesda assay, or history of periods with low recovery and no response to Factor VIII treatment
• •4. Demonstrated an inability to respond to conventional doses of FVIII therapy
• •5. History of incremental recovery of Factor VIII \<1.35% per IU/kg infused
• •6. Hematological disorders or blood coagulation diseases (e.g., idiopathic thrombocytopenic purpura, von Willebrand disease, etc.) other than hemophilia A
• •7. Laboratory or clinical evidence of portal vein hypertension including,(but not limited to, an INR \> 1.4, the presence of splenomegaly and/or spider angiomata on physical examination and/or a history of esophageal hemorrhage or documented esophageal varices
• •8. Uncontrolled hypertension (diastolic blood pressure \>100 mm Hg)
• •9. Hemoglobin \< 10 g.dL
• •10. HIV disease symptoms regardless of presence of HIV antibodies
• •11. Routine administration (or planned routine administration during the course of the study), of immunosuppressive or immunomodulating drugs other than antiretroviral therapy (e.g., steroids, beta-interferon)
• •12. Severe renal dysfunction (creatinine \> 2x upper limit of normal \[ULN\], total bilirubin \> 2x the ULN)
• •13. Liver disease (alanine aminotransferase \[ALT\], aspartate aminotransferase \[ AST\] \> 3x the ULN)
• •14. History of diabetes or other metabolic disease
• •15. History of hypersensitivity or serious adverse reaction to recombinant or plasma-derived FVIII concentrate
• •16. History of pretreatment prior to the administration of FVIII products (e.g., of antihistamines)
• •17. Regular use of antifibrinolytics or medications affecting platelet function
• •18. Hypersensitivity to hamster-or mouse derived proteins
• •19. Blood transfusions within 30 days of enrollment into the study
• •20. Current participation in another investigational drug or device study, or participated in a clinical study involving an investigational drug or device within 30 days of enrollment into the study
• •21. Unable or unwilling to cooperate with study procedures