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A Comparison between Recombinant Activated Factor VII (Aryoseven) and Novoseven in Patients with Congenital Factor VII Deficiency

Faranoush, M. and Abolghasemi, H. and Toogeh, G. and Karimi, M. and Eshghi, P. and Managhchi, M. and Hoorfar, H. and Dehdezi, B.K. and Mehrvar, A. and Khoeiny, B. and Kamyar, K. and Heshmat, R. and Baghaeipour, M.R. and Mirbehbahani, N.B. and Fayazfar, R. and Ahmadinejad, M. and Naderi, M. (2015) A Comparison between Recombinant Activated Factor VII (Aryoseven) and Novoseven in Patients with Congenital Factor VII Deficiency. Clinical and Applied Thrombosis/Hemostasis, 21 (8). pp. 724-728.

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Abstract

In order to establish the efficacy and biosimilar nature of AryoSeven to NovoSeven in the treatment of congenital factor VII (FVII) deficiency, patients received either agent at 30 1/4g/kg, intravenously per week for 4 weeks, in a randomized fashion. The primary aim was to compare FVII:coagulation activity (FVII:C), 20 minutes after recombinant activated FVII (rFVIIa) injection, in the 2 groups. A secondary measure was self-reported bleeding. The median interquartile baseline range of the plasma level of activated FVII (FVIIa) activity in the 2 groups was 1.6 (1.1-14.0) IU/dL and 5.0 (1.1-25.5) IU/dL. All patients achieved levels of FVIIa (FVII:C) >30 IU/dL, 20 minutes after the injection of rFVIIa. Bleeding was similar between the 2 groups, with a comparable decrease in severity and frequency compared to the last month prior to treatment. AryoSeven is similar to NovoSeven in increasing postinjection FVIIa activity as well as in clinical safety and efficacy. © The Author(s) 2014.

Item Type: Article
Additional Information: cited By 0
Uncontrolled Keywords: blood clotting factor 7; recombinant activated factor vii; recombinant blood clotting factor 7a; unclassified drug; blood clotting factor 7a; recombinant FVIIa; recombinant protein, adult; arthralgia; Article; blood clotting factor 7 deficiency; blood clotting test; blood pressure; brain hemorrhage; controlled study; disease severity; double blind procedure; drug eruption; drug safety; female; fever; headache; heart rate; human; kidney function test; major clinical study; male; multicenter study; nausea; priority journal; randomized controlled trial; self report; single drug dose; urticaria; adolescent; bleeding; blood; blood clotting; chemically induced; child; clinical trial; comparative study; drug effects; Factor VII Deficiency, Adolescent; Adult; Blood Coagulation; Child; Double-Blind Method; Factor VII Deficiency; Factor VIIa; Female; Hemorrhage; Humans; Male; Recombinant Proteins
Subjects: مقالات نمایه شده محققین دانشگاه در سایت ,Web of Science ,Scopus
Divisions: معاونت تحقیقات و فناوری
Depositing User: GOUMS
Date Deposited: 10 Sep 2016 09:20
Last Modified: 24 Dec 2016 07:57
URI: http://eprints.goums.ac.ir/id/eprint/4829

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