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Safety and efficacy of a sucrose‐formulated recombinant factor VIII product for the treatment of previously treated patients with haemophilia A in China
Author(s) -
SHI J.,
ZHAO Y.,
WU J.,
SUN J.,
WANG L.,
YANG R.
Publication year - 2007
Publication title -
haemophilia
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.213
H-Index - 92
eISSN - 1365-2516
pISSN - 1351-8216
DOI - 10.1111/j.1365-2516.2007.01472.x
Subject(s) - medicine , haemophilia a , haemophilia , adverse effect , recombinant dna , surgery , biochemistry , chemistry , gene
Summary. The use of plasma‐derived products has contributed to a high rate of blood‐borne infections among haemophilia patients in China. Recombinant factor VIII (rFVIII) products that are manufactured without human or bovine albumin and include dedicated viral inactivation steps, hold a significant safety advantage over plasma products. However, there is little information published on the use of rFVIII products in non‐caucasian populations. This is the first reported evaluation of the efficacy and safety of a rFVIII product in Chinese haemophiliacs. An open‐label, non‐randomized, prospective, multicentre trial enroled previously treated Chinese patients with haemophilia A. All treatments were administered using a sucrose‐formulated rFVIII‐FS (Kogenate ® ). Forty‐nine patients received totals of 291 infusions (mean, 5.94/patient) and 742 140 IU rFVIII‐FS (mean, 2550.3 IU/infusion). Of the 60 acute bleeding episodes that were treated, 90% were successfully managed with only one (81.7%) infusion or two (8.3%) infusions. Physicians reported haemostasis control for acute bleeds to be ‘Excellent’ or ‘Improved’ with rFVIII‐FS therapy. No FVIII inhibitors were detected in any patient. Only one treatment‐related adverse event was reported, which was mild dizziness that resolved spontaneously. rFVIII‐FS was efficacious, safe and well tolerated in the treatment of previously treated patients with haemophilia A in China.