Browsing by Author "Timur, Cetin"

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    Use of a High-Purity Factor X Concentrate in Turkish Subjects With Hereditary Factor X Deficiency: Post Hoc Cohort Subanalysis of a Phase 3 Study
    (Galenos Yayincilik, 2018) Oner, Ahmet F.; Celkan, Tiraje; Timur, Cetin; Norton, Miranda; Kavakli, Kaan
    Hereditary factor X (FX) deficiency is a rare bleeding disorder more prevalent in countries with high rates of consanguineous marriage. In a prospective, open-label, multicenter phase 3 study, 25 IU/kg plasma-derived factor X (pdFX) was administered as on-demand treatment or short-term prophylaxis for 6 months to 2 years. In Turkish subjects (n=6), 60.7% of bleeds were minor. A mean of 1.03 infusions were used to treat each bleed, and mean total dose per bleed was 25.38 IU/kg. Turkish subjects rated pdFX efficacy as excellent or good for all 84 assessable bleeds; investigators judged overall pdFX efficacy to be excellent or good for all subjects. Turkish subjects had 51 adverse events; 96% with known severity were mild/moderate, and 1 (infusion-site pain) was possibly pdFX-related. These results demonstrate that 25 IU/kg pdFX is safe and effective in this Turkish cohort