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 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.
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
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.