The study will consist of two parts: a safety and efficacy period in which all subjects will participate and a pharmacokinetic analysis period, in which 30 eligible subjects will participate to compare ReFacto AF and Advate bioequivalency and safety and efficacy of ReFacto AF in patients with Hemophilia A.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
100
To determine the incidence rate of Factor VIII inhibitors in the study patient population.To establish bioequivalence of ReFacto AF as compared to Advate using the one stage Factor VIII activity assay.
To characterize the efficacy of ReFActo AF in preventing and treating bleeding episodes during prophylaxis.To characterize PK of ReFacto AF as compared to Advate over time.
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Phoenix, Arizona, United States
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Sacramento, California, United States
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San Diego, California, United States
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Aurora, Colorado, United States
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Atlanta, Georgia, United States
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Iowa City, Iowa, United States
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New Orleans, Louisiana, United States
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Worcester, Massachusetts, United States
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East Lansing, Michigan, United States
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St Louis, Missouri, United States
...and 31 more locations