Study Evaluating On-Demand Treatment Of Xyntha In Chinese Subjects

An Evaluation Of The Safety And Efficacy Of On-Demand Treatment With Xyntha (B Domain Deleted Recombinant Factor VIII, Albumin Free) In Chinese Subjects With Hemophilia A

This study will evaluate the safety and efficacy of on-demand treatment with Xyntha in Chinese hemophilia A subjects.

Inclusion Criteria:

• Subjects equal or more than 6 years of age with mild, moderate or severe hemophilia A (FVIII activity: more than 5%, 1-5%, or less than 1%, respectively)
• Subjects with previous exposure to FVIII replacement therapy
• If human immunodeficiency virus (HIV) positive, documented cluster of differentiation (CD4) count more than 200/µL within 6 months of study entry

Exclusion Criteria:

• Diagnosed with any bleeding disorder in addition to hemophilia A
• Current FVIII inhibitor or history of FVIII inhibitor (defined as positive result of the reporting laboratory)
• Subject has no history of exposure to FVIII products (previously untreated patient [PUP])
• Subject is currently utilizing primary FVIII prophylaxis
• Subjects anticipating elective surgery that may be planned to occur in the 6 months following study entry
• Treated with immunomodulatory therapy within 30 days prior to study entry or planned use for the duration of their study participation
• Participated in another investigational drug or device study within 30 days prior to study entry or planned participation for the duration of their study participation
• Subjects with a known hypersensitivity to hamster protein
• Significant hepatic or renal impairment (alanine aminotransferase [ALT] and aspartate aminotransferase [AST] >5 x upper limit of normal [ULN], bilirubin >2 mg/dL or serum creatinine >1.25 x ULN)
• Prothrombin Time >1.5 x ULN
• Platelet count <80,000 / µL
• Pregnant or breastfeeding women
• Unwilling or unable to follow the terms of the protocol
• Any condition which may compromise the subject's ability to comply with and/or perform study-related activities or that poses a clinical contraindication to study participation, in the opinion of the Investigator or Sponsor