Efficacy and Safety of ADVATE Standard Prophylaxis to Hemophilia A

Launched by NANJING MEDICAL UNIVERSITY · Oct 29, 2014

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Eligibility criteria

• Inclusion Criteria:
• • 1. Subject has hemophilia A with FVIII≤2 %.
• • 2. Previously treated patients (PTPs).
• • 3. Age from 2 to 18 years.
• Exclusion Criteria:
• • 1. Subject has known hypersensitivity to the active substance or any of the excipients.
• • 2. Subject has known allergic reaction to mouse or hamster proteins.
• • 3. Subject has participated in another clinical study involving an investigational product (IP) or device within 30 days prior to study enrollment or is scheduled to participate in another clinical study involving another FVIII concentrate or device during the course of this study.
• • 4. Subject is planned, or likely to have surgery during the study period.
• • 5. Subject has end-stage renal failure or evidence of a severe or uncontrolled systemic disease as judged by the investigator.
• • 6. Subject has full-blown Acquired Immuno Deficiency Syndrome (AIDS),determined by Cluster Determinant 4+(CD4+) and clinical presentation.
• • 7. Subject has active hepatic disease (alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels \> 5 times the upper limit of normal).
• • 8. Subject has clinical or laboratory evidence of severe liver impairment including (but not limited to) a recent and persistent international normalized ratio (INR)\> 1.4, and/or the presence of splenomegaly and/or significant spider angioma on physical exam, and/or a history of esophageal hemorrhage or documented esophageal varices.
• • 9. The subject in the opinion of the investigator is unable or unwilling to comply with study protocol
• • 10. Subject is a family member of the investigator or site staff