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1 Study Matches

An Open-label, Non-investigational Product, Multi-center, Lead-in Study to Evaluate Prospective Bleeding and Infusion Data of Current FVIII Replacement Therapy in Adult Males with Hemophilia A

SPK-8011-301 is an open-label, non-investigational product lead-in study to collect efficacy and selected safety data on frequency and type of bleeding episodes and FVIII prophylaxis replacement therapy in the usual care setting of adult males with clinically severe hemophilia A (i.e., ≤ 2% IU/dL FVIII activity level), who are negative for neutralizing antibody (Nab) to AAV-Spark200.
Cynthia Campbell-Baird, RN at or 717-531-5777
18 year(s) or older
This study is NOT accepting healthy volunteers
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Inclusion Criteria:
Clinically severe Hemophilia A
Patients on prophylactic regimen > 2 months
Previous exposure to FVIII therapy
No history of hypersensitivity or anaphylaxis with any FVIII or IV immunoglobulin product
No measurable inhibitor against FVIII
Exclusion Criteria:
Active Hepatitis B or C within past 12 months
Current use of antiviral therapy to treat Hepatitis B or C
Documented significant liver disease
Serological evidence of HIV-1 or HIV-2
Anti-AAV-Spark neutralizing antibody titers >1:1
Blood Disorders
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Hershey, PA