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Blood, 15 January 2007, Vol. 109, No. 2, pp. 546-551. Prepublished online as a Blood First Edition Paper on September 21, 2006; DOI 10.1182/blood-2006-04-017988. This Article Full Text Full Text (PDF) Supplemental Appendix All Versions of this Article: blood-2006-04-017988v1 109/2/546    most recent Alert me when this article is cited Alert me if a correction is posted Citation Map Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Rights and Permissions Citing Articles Citing Articles via HighWire Citing Articles via CrossRef Citing Articles via Google Scholar Google Scholar Articles by Astermark, J. Articles by Berntorp, E. Search for Related Content PubMed PubMed Citation Articles by Astermark, J. Articles by Berntorp, E. Related Collections Hemostasis, Thrombosis, and Vascular Biology Free Research Articles Clinical Trials and Observations Related Article in Blood Online Social Bookmarking                   What's this?  Previous Article  |  Table of Contents  |  Next Article  HEMOSTASIS, THROMBOSIS, AND VASCULAR BIOLOGY A randomized comparison of bypassing agents in hemophilia complicated by an inhibitor: the FEIBA NovoSeven Comparative (FENOC) Study Jan Astermark1,, Sharyne M. Donfield2, Donna M. DiMichele3, Alessandro Gringeri4, Steven A. Gilbert2, Jennifer Waters2, Erik Berntorp1, for the FENOC Study Group 1 Department for Hematology and Coagulation Disorders, Malmö University Hospital, Malmö, Sweden; 2 Department of Biostatistics, Rho, Chapel Hill, NC; 3 Department of Pediatrics, Weill Medical College, Cornell University, New York, NY; 4 Angelo Bianchi Bonomi Hemophilia and Thrombosis Center, University of Milan, Italy 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 VIIa (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 [ClinicalTrials.gov] . CiteULike    Connotea    Del.icio.us    Digg    Reddit    Technorati    What's this? Related Article in Blood Online: A "joint" statement on inhibitor-bypassing therapy W. Keith Hoots Blood 2007 109: 395-396. [Full Text] [PDF] This article has been cited by other articles: K. A. Tanaka, N. S. Key, and J. H. Levy Blood Coagulation: Hemostasis and Thrombin Regulation Anesth. Analg., May 1, 2009; 108(5): 1433 - 1446. [Abstract] [Full Text] [PDF] C. L. Kempton and G. C. White II How we treat a hemophilia A patient with a factor VIII inhibitor Blood, January 1, 2009; 113(1): 11 - 17. [Abstract] [Full Text] [PDF] K. Mytopher MD, J. Dudebout MD, R. Card MD, and B. Gilliland MD Acquired hemophilia A presenting post partum Can. Med. Assoc. J., August 14, 2007; 177(4): 339 - 340. [Full Text] [PDF] Activated Prothrombin Complex or Factor VIIa for Refractory Hemophilia? Journal Watch Oncology and Hematology, February 12, 2007; 2007(212): 2 - 2. [Full Text]

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