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A randomized comparison of bypassing agents in hemophilia complicated by an inhibitor.

Astermark, Jan LU ; Donfield, Sharyne M; Dimichele, Donna M; Gringeri, Alessandro; Gilbert, Steven A; Waters, Jennifer and Berntorp, Erik LU (2007) In Blood 109(Sep 21). p.546-551
Abstract
The development of inhibitory antibodies to factor VIII is a serious complication of hemophilia. FEIBA (factor VIII inhibitor-bypassing activity), an activated prothrombin complex concentrate (aPCC), and NovoSeven, recombinant factor Vila (rFVIIa), are used as hemostatic bypassing agents in treating patients with inhibitors. The FENOC study was designed to test equivalence of the products in the treatment of ankle, knee, and elbow joint bleeding. A prospective, open-label, randomized, crossover, equivalency design was used. The parameters of interest were the percentage of patients who reported efficacy in response to FEIBA and the percentage that reported efficacy in response to NovoSeven. A difference in these percentages of no more than... (More)
The development of inhibitory antibodies to factor VIII is a serious complication of hemophilia. FEIBA (factor VIII inhibitor-bypassing activity), an activated prothrombin complex concentrate (aPCC), and NovoSeven, recombinant factor Vila (rFVIIa), are used as hemostatic bypassing agents in treating patients with inhibitors. The FENOC study was designed to test equivalence of the products in the treatment of ankle, knee, and elbow joint bleeding. A prospective, open-label, randomized, crossover, equivalency design was used. The parameters of interest were the percentage of patients who reported efficacy in response to FEIBA and the percentage that reported efficacy in response to NovoSeven. A difference in these percentages of no more than 15% was determined to be a clinically acceptable magnitude for equivalence of the 2 products. The primary outcome was evaluation 6 hours after treatment. Data for 96 bleeding episodes contributed by 48 participants were analyzed. The criterion for declaring the 2 products equivalent at 6 hours was not met; however, the confidence interval of the difference in percentages of efficacy reported for each product only slightly exceeded the 15% boundary (-11.4%-15.7%), P=.059. FEIBA and NovoSeven appear to exhibit a similar effect on joint bleeds, although the efficacy between products is rated differently by a substantial proportion of patients. This trial was registered at www.clinicaltrials.gov as #NCT00166309. (Less)
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author
organization
publishing date
type
Contribution to journal
publication status
published
subject
in
Blood
volume
109
issue
Sep 21
pages
546 - 551
publisher
American Society of Hematology
external identifiers
  • wos:000243416600029
  • scopus:33846185403
ISSN
1528-0020
DOI
10.1182/blood-2006-04-017988
language
English
LU publication?
yes
id
28502113-8bb1-4fa4-8722-5122280a4d21 (old id 160877)
alternative location
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=16990605&dopt=Abstract
date added to LUP
2007-07-11 14:42:10
date last changed
2017-11-19 03:26:23
@article{28502113-8bb1-4fa4-8722-5122280a4d21,
  abstract     = {The development of inhibitory antibodies to factor VIII is a serious complication of hemophilia. FEIBA (factor VIII inhibitor-bypassing activity), an activated prothrombin complex concentrate (aPCC), and NovoSeven, recombinant factor Vila (rFVIIa), are used as hemostatic bypassing agents in treating patients with inhibitors. The FENOC study was designed to test equivalence of the products in the treatment of ankle, knee, and elbow joint bleeding. A prospective, open-label, randomized, crossover, equivalency design was used. The parameters of interest were the percentage of patients who reported efficacy in response to FEIBA and the percentage that reported efficacy in response to NovoSeven. A difference in these percentages of no more than 15% was determined to be a clinically acceptable magnitude for equivalence of the 2 products. The primary outcome was evaluation 6 hours after treatment. Data for 96 bleeding episodes contributed by 48 participants were analyzed. The criterion for declaring the 2 products equivalent at 6 hours was not met; however, the confidence interval of the difference in percentages of efficacy reported for each product only slightly exceeded the 15% boundary (-11.4%-15.7%), P=.059. FEIBA and NovoSeven appear to exhibit a similar effect on joint bleeds, although the efficacy between products is rated differently by a substantial proportion of patients. This trial was registered at www.clinicaltrials.gov as #NCT00166309.},
  author       = {Astermark, Jan and Donfield, Sharyne M and Dimichele, Donna M and Gringeri, Alessandro and Gilbert, Steven A and Waters, Jennifer and Berntorp, Erik},
  issn         = {1528-0020},
  language     = {eng},
  number       = {Sep 21},
  pages        = {546--551},
  publisher    = {American Society of Hematology},
  series       = {Blood},
  title        = {A randomized comparison of bypassing agents in hemophilia complicated by an inhibitor.},
  url          = {http://dx.doi.org/10.1182/blood-2006-04-017988},
  volume       = {109},
  year         = {2007},
}