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Arandomized comparison of bypassing agents in hemophilia complicated by an inhibitor: the FEIBA NovoSeven Comparative (FENOC) Study.

Astermark, Jan LU ; Donfield, Sh M.; DiMichele, D. M.; Gringeri, A.; Gilbert, S. A.; Waters, J. and Berntorp, Erik LU (2009) In Gematologiâ i Transfuziologiâ 54(5). p.35-35
Abstract
Arandomized comparison of bypassing agents in hemophilia complicated by an inhibitor: the FEIBA NovoSeven Comparative (FENOC) Study. J. Astermark(1), Sh. M. Donfield(2), D. M. DiMichele(3), A. Gringeri(4), S. A. Gilbert(2), J. Waters(2), E. Berntorp(1), for the FENOC Study Group. Department for Hematology and Coagulation Disorders, Malmo, University Hospital, Malmo, Sweden(1); Department of Biostatistics, Rho, Chapel Hill, NC2; Department of Pediatrics, Weill Medical College, Cornell University, New York, NY3; Angelo Bianchi Bonomi Hemophilia and Thrombosis Center, University of Milan, Italy(4). The development of inhibitory antibodies to factor VIII is a serious complication of hemophilia. FEIBA (factor VIII inhibitorbypassing activity),... (More)
Arandomized comparison of bypassing agents in hemophilia complicated by an inhibitor: the FEIBA NovoSeven Comparative (FENOC) Study. J. Astermark(1), Sh. M. Donfield(2), D. M. DiMichele(3), A. Gringeri(4), S. A. Gilbert(2), J. Waters(2), E. Berntorp(1), for the FENOC Study Group. Department for Hematology and Coagulation Disorders, Malmo, University Hospital, Malmo, Sweden(1); Department of Biostatistics, Rho, Chapel Hill, NC2; Department of Pediatrics, Weill Medical College, Cornell University, New York, NY3; Angelo Bianchi Bonomi Hemophilia and Thrombosis Center, University of Milan, Italy(4). The development of inhibitory antibodies to factor VIII is a serious complication of hemophilia. FEIBA (factor VIII inhibitorbypassing 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 = 0.059. 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. (Less)
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author
organization
publishing date
type
Contribution to journal
publication status
published
subject
keywords
recombinant factor VIIa, anti-inhibitor coagulant complex, inhibitor form of hemophilia A, inhibitor antibodies to factor VIII, FENOC study
in
Gematologiâ i Transfuziologiâ
volume
54
issue
5
pages
35 - 35
publisher
Ministerstvo Zdravookhraneniya
external identifiers
  • wos:000272685900008
ISSN
0234-5730
language
Russian
LU publication?
yes
id
54c6a831-f511-4d28-9008-05cda9a62d10 (old id 1532347)
date added to LUP
2010-01-29 11:07:12
date last changed
2016-04-15 21:32:30
@article{54c6a831-f511-4d28-9008-05cda9a62d10,
  abstract     = {Arandomized comparison of bypassing agents in hemophilia complicated by an inhibitor: the FEIBA NovoSeven Comparative (FENOC) Study. J. Astermark(1), Sh. M. Donfield(2), D. M. DiMichele(3), A. Gringeri(4), S. A. Gilbert(2), J. Waters(2), E. Berntorp(1), for the FENOC Study Group. Department for Hematology and Coagulation Disorders, Malmo, University Hospital, Malmo, Sweden(1); Department of Biostatistics, Rho, Chapel Hill, NC2; Department of Pediatrics, Weill Medical College, Cornell University, New York, NY3; Angelo Bianchi Bonomi Hemophilia and Thrombosis Center, University of Milan, Italy(4). The development of inhibitory antibodies to factor VIII is a serious complication of hemophilia. FEIBA (factor VIII inhibitorbypassing 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 = 0.059. 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.},
  author       = {Astermark, Jan and Donfield, Sh M. and DiMichele, D. M. and Gringeri, A. and Gilbert, S. A. and Waters, J. and Berntorp, Erik},
  issn         = {0234-5730},
  keyword      = {recombinant factor VIIa,anti-inhibitor coagulant complex,inhibitor form of hemophilia A,inhibitor antibodies to factor VIII,FENOC study},
  language     = {rus},
  number       = {5},
  pages        = {35--35},
  publisher    = {Ministerstvo Zdravookhraneniya},
  series       = {Gematologiâ i Transfuziologiâ},
  title        = {Arandomized comparison of bypassing agents in hemophilia complicated by an inhibitor: the FEIBA NovoSeven Comparative (FENOC) Study.},
  volume       = {54},
  year         = {2009},
}