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A Comparison Between Recombinant Activated Factor Vii (Aryoseven) and Novoseven in Patients With Congenital Factor Vii Deficiency Publisher Pubmed



Faranoush M1 ; Abolghasemi H2 ; Toogeh G3 ; Karimi M4 ; Eshghi P2 ; Managhchi M3 ; Hoorfar H5 ; Dehdezi BK6 ; Mehrvar A7 ; Khoeiny B8 ; Kamyar K8 ; Heshmat R3 ; Baghaeipour MR9 ; Mirbehbahani NB10 Show All Authors
Authors
  1. Faranoush M1
  2. Abolghasemi H2
  3. Toogeh G3
  4. Karimi M4
  5. Eshghi P2
  6. Managhchi M3
  7. Hoorfar H5
  8. Dehdezi BK6
  9. Mehrvar A7
  10. Khoeiny B8
  11. Kamyar K8
  12. Heshmat R3
  13. Baghaeipour MR9
  14. Mirbehbahani NB10
  15. Fayazfar R11
  16. Ahmadinejad M12
  17. Naderi M13
Show Affiliations
Authors Affiliations
  1. 1. High Institute of Research, Iranian Blood Transfusion Organization, Iran University of Medical Sciences, Rasool Akram Hospital, Tehran, Iran
  2. 2. Shahid Beheshti University of Medical Sciences, Tehran, Iran
  3. 3. Tehran University of Medical Sciences, Thrombosis and Hemostasis Research Center, Tehran, Iran
  4. 4. Shiraz University of Medical Sciences, Shiraz, Iran
  5. 5. Isfahan University of Medical Sciences, Isfahan, Iran
  6. 6. Ahwaz University of Medical Sciences, Ahwaz, Iran
  7. 7. MAHAK Childrens Hospital, Tehran, Iran
  8. 8. Aryogen Zist Darou Company, Karaj, Iran
  9. 9. Iranian Comprehensive Hemophilia Care Center, Tehran, Iran
  10. 10. Golestan University of Medical Sciences, Gorgan, Iran
  11. 11. Kerman University of Medical Sciences, Kerman, Iran
  12. 12. IBTO, Tehran, Iran
  13. 13. Zahedan University of Medical Sciences, Ahwaz, Iran

Source: Clinical and Applied Thrombosis/Hemostasis Published:2015


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.