Study Evaluating On-Demand Treatment Of Xyntha In Chinese Subjects
Condition: Hemophilia A
MeSH terms: Hemophilia A
Intervention: Xyntha
Intervention description: Xyntha for on-demand treatment of bleeding episodes were according to investigator prescription during the 6 months observation period. The recovery assessed by determining the Factor VIII (FVIII) concentration (FVIII:C) levels in individual subjects at the initial and final visits. The dose of Xyntha for recovery assessments is: single 50 IU/kg (±5 IU/kg) IV bolus infusion. All Xyntha administrations occurred in the clinic (hospital).
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 53.0
Sex: All
Minimum age: 6 Years
Healthy volunteers: No
Keywords: On-demand treatment; Hemostatic Efficacy Assessments; Factor VIII recovery; Factor VIII Inhibitor; Chinese

Summary:

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

Eligibility criteria:

        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