title: A comparison between recombinant activated factor VII (Aryoseven) and Novoseven in patients with congenital factor VII deficiency.
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 μg/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.
authors.affiliation: High Institute of Research, Iranian Blood Transfusion Organization, Iran University of Medical Sciences, Rasool Akram Hospital, Tehran, Iran.
authors.forename: M
authors.initials: M
authors.lastname: Faranoush
authors.affiliation: Shahid Beheshti University of Medical Sciences, Tehran, Iran h.abolghasemi@sbmu.ac.ir.
authors.forename: Hassan
authors.initials: H
authors.lastname: Abolghasemi
authors.affiliation: Tehran University of Medical Sciences, Thrombosis and Hemostasis Research Center, Tehran, Iran.
authors.forename: Gh
authors.initials: G
authors.lastname: Toogeh
authors.affiliation: Shiraz University of Medical Sciences, Shiraz, Iran.
authors.forename: M
authors.initials: M
authors.lastname: Karimi
authors.affiliation: Shahid Beheshti University of Medical Sciences, Tehran, Iran.
authors.forename: P
authors.initials: P
authors.lastname: Eshghi
authors.affiliation: Tehran University of Medical Sciences, Thrombosis and Hemostasis Research Center, Tehran, Iran.
authors.forename: M
authors.initials: M
authors.lastname: Managhchi
authors.affiliation: Isfahan University of Medical Sciences, Isfahan, Iran.
authors.forename: H
authors.initials: H
authors.lastname: Hoorfar
authors.affiliation: Ahwaz University of Medical Sciences, Ahwaz, Iran.
authors.forename: B Keikhaei
authors.initials: BK
authors.lastname: Dehdezi
authors.affiliation: MAHAK Children's Hospital, Tehran, Iran.
authors.forename: A
authors.initials: A
authors.lastname: Mehrvar
authors.affiliation: Aryogen Zist Darou Company, Karaj, Iran.
authors.forename: B
authors.initials: B
authors.lastname: Khoeiny
authors.affiliation: Aryogen Zist Darou Company, Karaj, Iran.
authors.forename: K
authors.initials: K
authors.lastname: Kamyar
authors.affiliation: Tehran University of Medical Sciences, Thrombosis and Hemostasis Research Center, Tehran, Iran.
authors.forename: R
authors.initials: R
authors.lastname: Heshmat
authors.affiliation: Iranian Comprehensive Hemophilia Care Center, Tehran, Iran.
authors.forename: M R
authors.initials: MR
authors.lastname: Baghaeipour
authors.affiliation: Golestan University of Medical Sciences, Gorgan, Iran.
authors.forename: N B
authors.initials: NB
authors.lastname: Mirbehbahani
authors.affiliation: Kerman University of Medical Sciences, Kerman, Iran.
authors.forename: R
authors.initials: R
authors.lastname: Fayazfar
authors.affiliation: IBTO, Tehran, Iran.
authors.forename: M
authors.initials: M
authors.lastname: Ahmadinejad
authors.affiliation: Zahedan University of Medical Sciences, Ahwaz, Iran.
authors.forename: M
authors.initials: M
authors.lastname: Naderi
mesh_terms: D000293:Adolescent; D000328:Adult; D001777:Blood Coagulation / Q000187:drug effects; D002648:Child; D004311:Double-Blind Method; D005168:Factor VII Deficiency / Q000097:blood / Q000188:drug therapy*; D015942:Factor VIIa / Q000008:administration & dosage* / Q000009:adverse effects / Q000493:pharmacokinetics*; D005260:Female; D006470:Hemorrhage / Q000097:blood / Q000139:chemically induced; D006801:Humans; D008297:Male; D011994:Recombinant Proteins / Q000008:administration & dosage / Q000009:adverse effects / Q000493:pharmacokinetics
chemical_list: D011994:Recombinant Proteins; C103587:recombinant FVIIa; D015942:Factor VIIa
keywords: AryoSeven; Iran; NovoSeven; deficiency; factor VII; hereditary