Study Evaluating On-Demand Treatment Of Xyntha In Chinese Subjects
Study Evaluating On-Demand Treatment Of Xyntha In Chinese Subjects
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