PF-05208756, Moroctocog Alfa (AF-CC), Xyntha For Hemophilia A
Condition: Hemophilia A
MeSH terms: Hemophilia A
Intervention: Intravenous infusions of Xyntha
Intervention description: Enrolled subjects will be treated with intravenous infusions of Xyntha for: • On-Demand treatment, • Surgical Prophylaxis at a dose and frequency prescribed by the subject's treating physician in accordance with the Xyntha label and will be adjusted solely according to medical and therapeutic necessity.
Intervention MeSH terms: Factor VIII
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 85.0
Sex: All
Healthy volunteers: No
Keywords: FVIII inhibitor

Summary:

      An open-label, single-arm, post- authorization pragmatic clinical trial on the safety and
      efficacy of Xyntha (Moroctocog-alfa (AF-CC), Recombinant FVIII) in subjects with hemophilia A
      in usual care settings in China for approximately 6 months or or approximately 50 exposure
      days whichever occurs first
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and/or Female subjects with Hemophilia A.

          -  Subjects/parents/legal representatives must be able to comply with registry procedures
             (informed consent/assent process, clinical visits, reporting of infusion and bleed
             data, reporting of adverse events, etc).

          -  Evidence of a personally signed and dated informed consent document indicating that
             the subject (or a legally acceptable representative, parent(s)/legal guardian) has
             been informed of all pertinent aspects of the study.

        Exclusion Criteria:

          -  Presence of any other bleeding disorder in addition to hemophilia A.

          -  Treatment with immunomodulatory therapy (e.g., intravenous immunoglobulin, routine
             systemic corticosteroids, cyclosporins, anti-TNF agents) within 30 days prior to study
             entry or planned use for the duration of their study participation.

          -  Subjects with a past history of, or current factor VIII inhibitor. For
             laboratory-based assessments, any Bethesda inhibitor titer greater than the
             laboratory's normal range or ≥0.6 BU/mL.

          -  Subjects with known hypersensitivity to the active substance or to any of the
             excipients of Xyntha.

          -  Subjects with a known hypersensitivity to Chinese Hamster Ovary cell proteins.

          -  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 (these conditions include, but are not limited to, inadequate medical
             history to assure study eligibility; expectation of poor compliance in provision of
             observations for study-related documentation), in the opinion of the Investigator.

          -  Participation in other studies involving investigational drug(s) (Phases 1-4) within
             30 days before the current study begins and/or during study participation (exception
             for studies on Xyntha).

          -  Subjects who are investigational site staff members directly involved in the conduct
             of the study and their family members, site staff members otherwise supervised by the
             Investigator, or subjects who are Pfizer employees directly involved in the conduct of
             the study.