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Clinical studies of...
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Hermans, CedricSaint-Luc University Hospital
(författare)
Clinical studies of extended-half-life recombinant FVIII products for prophylaxis in adults and children : A critical review from the physician's perspective
- Artikel/kapitelEngelska2022
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Nummerbeteckningar
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LIBRIS-ID:oai:lup.lub.lu.se:9abe4610-4ea7-4e4c-b6f5-7013e2b32a96
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https://lup.lub.lu.se/record/9abe4610-4ea7-4e4c-b6f5-7013e2b32a96URI
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https://doi.org/10.1016/j.critrevonc.2022.103678DOI
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Språk:engelska
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Sammanfattning på:engelska
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Ämneskategori:for swepub-publicationtype
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Ämneskategori:ref swepub-contenttype
Anmärkningar
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This review compares the methodology of published clinical studies investigating the extended-half-life (EHL) factor VIII (FVIII) products, rFVIIIFc (efmoroctocog alfa, Elocta®/Eloctate®), BAY 94-9027 (damoctocog alfa pegol, Jivi®), BAX 855 (rurioctocog alfa pegol, Adynovate®) and N8-GP (turoctocog alfa pegol, Esperoct®) including the phase 2/3 studies, A-LONG (NCT01181128), PROTECT VIII (NCT01580293), PROLONG-ATE (NCT01736475) and pathfinder2 (NCT01480180), respectively, and their corresponding pediatric studies and extensions. Study results are interpreted from a treating physician's perspective, translating into evidence-based, real-life use of the different EHL recombinant FVIII products for personalized prophylaxis. The similarities between the studies include methodology, objectives, study design and cohort size. The differences include duration, prophylactic dosing intervals, number of patient arms, use of control group and randomization, and treatment allocation. Comparing these studies broadens physicians’ understanding of each treatment's applicability. Further evaluation of study data and future real-world studies should help physicians to confidently individualize and select treatment for each patient.
Ämnesord och genrebeteckningar
Biuppslag (personer, institutioner, konferenser, titlar ...)
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Reding, Mark T.University of Minnesota Medical School
(författare)
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Astermark, JanLund University,Lunds universitet,Institutionen för translationell medicin,Medicinska fakulteten,Department of Translational Medicine,Faculty of Medicine(Swepub:lu)medf-jas
(författare)
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Klamroth, RobertVivantes Humboldt Hospital
(författare)
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Mancuso, Maria ElisaHumanitas Research Hospital
(författare)
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Saint-Luc University HospitalUniversity of Minnesota Medical School
(creator_code:org_t)
Sammanhörande titlar
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Ingår i:Critical Reviews in Oncology/Hematology: Elsevier BV1741040-8428
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