Blood Coagulation & Fibrinolysis · 2 authors, 2 centres
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This observational study evaluated the effectiveness and safety of recombinant activated FVII (rFVIIa) in Japanese patients with congenital factor VII deficiency. The central result was that rFVIIa treatment was highly effective for achieving hemostasis in bleeding episodes and during surgery.
It collected data on 55% of the 64 registered patients with congenital factor VII deficiency who were treated with recombinant activated FVII (rFVIIa). The primary endpoint to evaluate safety was not met due to the small sample size and real-world setting. For the secondary effectiveness endpoint, the study found that rFVIIa treatment, administered at the recommended dose of 15–30 μg/kg, was highly effective in achieving rapid hemostasis for both bleeding episodes and surgical procedures, with most patients requiring a low number of doses. Limitations include the small sample size and incomplete data due to the disease's rarity. The study supports previous reports that rFVIIa is effective in routine clinical practice for this condition in Japan.
