Study of PF-05208756, Moroctocog Alfa (AF-CC), Xyntha For Male Chinese Subjects With Hemophilia A
Condition: Hemophilia A
MeSH terms: Hemophilia A
Intervention: Intravenous infusions of Xyntha
Intervention description: A single dose 50IU/kg dose of Xyntha administered by intravenous infusion within 10 minutes on Day 1
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Masking: None (Open Label)
Enrollment: 13.0
Sex: Male
Minimum age: 6 Years
Healthy volunteers: No
Keywords: FVIII activity

Summary:

      An open-label, single dose pharmacokinetic study of Xyntha (Moroctocog Alfa (AF-CC),
      Recombinant Factor VIII) in male Chinese subjects with hemophilia A
    

Eligibility criteria:

        Inclusion Criteria:

        Subjects must meet all of the following inclusion criteria to be eligible for enrollment in
        the study:

          1. Male Chinese subjects 6 years or older (weight >20 kg) with severe hemophilia A
             (factor VIII activity <1%) previously treated with > 150 exposure days to any
             FVIII-containing products.

          2. Subjects should not have received an infusion of any FVIII products for at least 3
             days (at least 72 hours) before the administration of Xyntha on Day 1.

          3. Subjects must be in a non bleeding state before the administration of Xyntha on Day 1.

          4. Evidence of a personally or legally acceptable representative (legally acceptable
             representative is only applicable to pediatric subjects) signed and dated informed
             consent document indicating that the subject has been informed of all pertinent
             aspects of the study.

          5. Subjects who are willing and able to comply with scheduled visits, treatment plan,
             laboratory tests, and other study procedures.

        Exclusion Criteria:

        Subjects with any of the following characteristics/conditions will not be included in the
        study:

          1. Current FVIII inhibitor or history of FVIII inhibitor (defined as > upper limit of
             normal (ULN) of the local reporting laboratory).

          2. Evidence or history of clinically significant hematological, renal, endocrine,
             pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or
             allergic disease (including drug allergies, but excluding untreated, asymptomatic,
             seasonal allergies at time of dosing) or clinical findings at Screening.

          3. Diagnosed with any other bleeding disorder in addition to hemophilia A.

          4. Documented Human Immunodeficiency Virus (HIV).

          5. Subjects anticipating elective surgery or other invasive procedure within 1 month
             following study entry.

          6. Treatment with immunomodulatory therapy within 30 days or 5 half lives whichever is
             longer, prior to study entry or planned use for the duration of study participation.

          7. Subjects with known hypersensitivity to the active substance or to any of the
             excipients of Xyntha.

          8. Subjects with a known hypersensitivity to Chinese Hamster Ovary cell (CHO cell)
             proteins.

          9. Subjects with ANY of the following abnormalities in clinical laboratory tests at
             screening, as assessed by the study specific laboratory and confirmed by a single
             repeat, if deemed necessary: significant hepatic or renal impairment (alanine
             aminotransferase (ALT) or aspartate aminotransferase (AST) >3 x ULN, or total
             bilirubin >2 x ULN or serum creatinine >2 x ULN), prothrombin time >1.5 x ULN,
             platelet count <80,000 L. Subjects with Gilbert's disease may be enrolled.

         10. Unwilling or unable to follow the terms of the protocol.

         11. 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.

         12. A positive urine drug screen.

         13. History of regular alcohol consumption exceeding 14 drinks/week (1 drink = 5 ounces
             (150 mL) of wine, 12 ounces (360 mL) of beer, or 1.5 ounces (45 mL) of hard liquor)
             within 6 months of screening.

         14. Treatment with an investigational drug within 30 days or 5 half lives preceding Day 1,
             whichever is longer.

         15. Screening supine blood pressure 140 mm Hg (systolic) or 90 mm Hg (diastolic),
             following at least 5 minutes of supine rest. If blood pressure (BP) is 140 mm Hg
             (systolic) or 90 mm Hg (diastolic), the BP should be repeated two more times and the
             average of the three BP values should be used to determine the subject's eligibility.

         16. Screening supine 12 lead ECG demonstrating QTcF >450 or a QRS interval >120 msec msec.
             If QTcF exceeds 450 msec, or QRS exceeds 120 msec, the ECG should be repeated two more
             times and the average of the three QTcF values should be used to determine the
             subject's eligibility.

         17. Blood donation (excluding plasma donations) of approximately 500 mL or more within 56
             days prior to dosing.

         18. History of sensitivity to heparin or heparin induced thrombocytopenia.

         19. Unwilling or unable to comply with the Lifestyle Guidelines described in this
             protocol.

         20. 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.

         21. Other severe acute or chronic medical or psychiatric condition or laboratory
             abnormality that may increase the risk associated with study participation or
             investigational product administration or may interfere with the interpretation of
             study results and, in the judgment of the investigator, would make the subject
             inappropriate for entry into this study.

         22. Subjects with history of infection within 1 week prior to study entry.

         23. Male subjects with partners currently pregnant and male subjects able to father
             children who are unwilling or unable to use a highly effective method of contraception
             as outlined in this protocol for the duration of the study and for at least 28 days
             after the last dose of investigational product.