Study Evaluating BDDRFVIII and ReFacto AF in Hemophilia A
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A Single Dose, Randomized, Double-Blind, 2-Period Crossover Study in Patients With Hemophilia A to Evaluate the Pharmacokinetics of B-Domain Deleted Recombinant Human Factor VIII (BDDrFVIII) Manufactured by the Current Process (ReFacto) and by an Albumin Free Manufacturing Process (ReFacto AF)
Actual Primary Completion Date
Actual Study Completion Date
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Ages Eligible for Study:
12 Years and older (Child, Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Severe hemophilia A (FVIII:C < 1% at local laboratory)
Previously treated patients (PTP) with at least 250 exposure days to any factor VIII product
Age greater than or equal to 12 years\
The presence of any bleeding disorder in addition to hemophilia A