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 [Kalıtsal faktör x eksikliği olan türk hastalarda yüksek saflıkta faktör x konsantresi kullanımı: Faz 3 çalışmasının post hoc kohort alt analizi]

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dc.contributor.authorÖner A.F.
dc.contributor.authorCelkan T.
dc.contributor.authorTimur Ç.
dc.contributor.authorNorton M.
dc.contributor.authorKavaklı K.
dc.date.accessioned2019-10-27T08:03:10Z
dc.date.available2019-10-27T08:03:10Z
dc.date.issued2018
dc.departmentEge Üniversitesien_US
dc.description.abstractHereditary 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 (ClinicalTrials.gov identifier: NCT00930176). ©2018 by Turkish Society of Hematologyen_US
dc.identifier.doi10.4274/tjh.2017.0446en_US
dc.identifier.endpage133en_US
dc.identifier.issn1300-7777
dc.identifier.issue2en_US
dc.identifier.pmid29545231en_US
dc.identifier.scopusqualityQ3en_US
dc.identifier.startpage129en_US
dc.identifier.urihttps://doi.org/10.4274/tjh.2017.0446
dc.identifier.urihttps://hdl.handle.net/11454/25312
dc.identifier.volume35en_US
dc.indekslendigikaynakScopusen_US
dc.indekslendigikaynakPubMeden_US
dc.language.isoenen_US
dc.publisherTurkish Society of Hematologyen_US
dc.relation.ispartofTurkish Journal of Hematologyen_US
dc.relation.publicationcategoryMakale - Uluslararası Hakemli Dergi - Kurum Öğretim Elemanıen_US
dc.rightsinfo:eu-repo/semantics/openAccessen_US
dc.subjectClinical trialen_US
dc.subjectClotting factor concentrateen_US
dc.subjectEfficacyen_US
dc.subjectFactor X deficiencyen_US
dc.subjectOrphan drugen_US
dc.subjectSafetyen_US
dc.titleUse of a high-purity factor x concentrate in turkish subjects with hereditary factor x deficiency: Post hoc cohort subanalysis of a phase 3 study [Kalıtsal faktör x eksikliği olan türk hastalarda yüksek saflıkta faktör x konsantresi kullanımı: Faz 3 çalışmasının post hoc kohort alt analizi]en_US
dc.typeArticleen_US

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