After laboratory and animal testing was completed, clinical studies with humans using rFIX were started. The first studies began in early 1995 in the United States, Europe, and Canada. To date, four clinical studies have evaluated the effectiveness of rFIX. These include a completed study comparing recovery and half-life of rFIX to those of a plasma-derived factor IX concentrate, a study of rFIX efficacy and safety for the prevention and control of bleeding in patients already exposed to factor concentrates, a completed study of patients using rFIX during surgery, and a trial of rFIX in patients who have never received any type of factor concentrate or blood product.
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