Safety and efficacy of turoctocog alfa (NovoEight®) during surgery in patients with haemophilia A: results from the multinational guardian™ clinical trials

E Santagostino; S. R Lentz; M Misgav; B Brand; P Chowdary; A Savic; Y Kilinc; Y Amit; A Amendola; L. P Solimeno; T Saugstrup; I Matytsina

doi:10.1111/hae.12518

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Safety and efficacy of turoctocog alfa (NovoEight®) during surgery in patients with haemophilia A: results from the multinational guardian™ clinical trials

Journal article

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Safety and efficacy of turoctocog alfa (NovoEight®) during surgery in patients with haemophilia A: results from the multinational guardian™ clinical trials

E Santagostino, S. R Lentz, M Misgav, B Brand, P Chowdary, A Savic, Y Kilinc, Y Amit, A Amendola, L. P Solimeno, …

Haemophilia : the official journal of the World Federation of Hemophilia, Vol.21(1), pp.34-40

01/2015

DOI: 10.1111/hae.12518

PMCID: PMC4309503

PMID: 25273984

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Abstract

Summary Recombinant factor VIII (rFVIII) products provide a safe and efficacious replacement therapy for prevention and treatment of bleeding episodes in patients with haemophilia A. The present investigations from the multinational, open‐label guardian™ clinical trials assessed the haemostatic response of turoctocog alfa (NovoEight®), a rFVIII product, in patients with severe haemophilia A (FVIII ≤ 1%) undergoing surgery. All patients had a minimum of 50 exposure days to any FVIII product prior to surgery and no history of inhibitors. A total of 41 procedures (13 orthopaedic, 19 dental and 9 general) were performed in 33 patients aged 4–59 years. Of the 41 procedures, 15 were major surgeries in 13 patients and 26 were minor surgeries in 21 patients. The success rate for haemostatic response was 100% (success was defined as ‘excellent’ or ‘good’ haemostatic outcome). Turoctocog alfa consumption on the day of surgery ranged from 27 to 153 IU kg−1. The mean daily dose declined over time, while retaining adequate FVIII coverage as measured by trough levels. Overall, no safety issues were identified. No thrombotic events were observed and none of the patients developed FVIII inhibitors. In conclusion, the present results show that turoctocog alfa was effective in controlling blood loss by obtaining a sufficient haemostatic response in patients with severe haemophilia A undergoing surgery.

clinical trial

turoctocog alfa

haemophilia A

recombinant factor VIII

NovoEight

surgery

Details

Title: Subtitle: Safety and efficacy of turoctocog alfa (NovoEight®) during surgery in patients with haemophilia A: results from the multinational guardian™ clinical trials
Creators: E Santagostino - IRCCS Ca' Granda Foundation, Maggiore Hospital Policlinico
S. R Lentz - The University of Iowa Carver College of Medicine
M Misgav - Tel Aviv University
B Brand - University Hospital
P Chowdary - Royal Free Hospital
A Savic - University of Novi Sad
Y Kilinc - Cukurova University
Y Amit - Tel Hashomer Hospital
A Amendola - University of Iowa
L. P Solimeno - ‘M.G. Gatti Randi’, CTO Hospital
T Saugstrup - Novo Nordisk A/S
I Matytsina - Novo Nordisk A/S
Resource Type: Journal article
Publication Details: Haemophilia : the official journal of the World Federation of Hemophilia, Vol.21(1), pp.34-40
DOI: 10.1111/hae.12518
PMID: 25273984
PMCID: PMC4309503
NLM abbreviation: Haemophilia
ISSN: 1351-8216
eISSN: 1365-2516
Number of pages: 7
Grant note: Novo Nordisk A/S
Language: English
Date published: 01/2015
Academic Unit: Hematology, Oncology, and Blood & Marrow Transplantation; Internal Medicine
Record Identifier: 9984094374002771

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