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Type: Artigo de periódico
Title: Updates From Guardian (tm): A Comprehensive Registration Programme
Author: Ozelo
Margareth C.
Abstract: Turoctocog alfa is an approved B-domain truncated recombinant factor VIII concentrate for adults and children with haemophilia A. Clinical data for turoctocog alfa have been reported from the guardian1, guardian2 and guardian3 phase III trials. guardian1 and guardian3 phase III trials enrolled 150 adolescents/adults (12yr), and 63 children (<12yr), respectively, with previously treated severe haemophilia A and no history of inhibitors; 188 of these patients continued into the ongoing guardian2 extension trial. In the three trials, patients have received prophylaxis with turoctocog alfa three times weekly or every second day, with breakthrough bleeds resolved to an expected postinjection level of 0.50IU/mL. No safety concerns have arisen, and no patients have developed confirmed inhibitors (primary endpoint). Indeed, no confirmed inhibitors have been detected in >200 patients treated for a cumulative total of >54000 exposure days in the phase III trials. Pooled efficacy data show a favourable long-term effect of turoctocog alfa on annualised bleeding rate and a success rate for haemostatic response of 86%; 90% of bleeds were resolved with 1-2 doses. This article reviews the clinical development of turoctocog alfa with reference to the guardian clinical programme, describing results obtained to date and ongoing trials.
Subject: Recombinant Factor-viii
Severe Hemophilia-a
Turoctocog Alpha Novoeight(r)
Prophylactic Treatment
Nijmegen Modification
Extension Trial
Bethesda Assay
C Inhibitors
Country: HOBOKEN
Rights: fechado
Identifier DOI: 10.1111/ejh.12648
Date Issue: 2015
Appears in Collections:Unicamp - Artigos e Outros Documentos

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