A randomized comparison of bypassing agents in hemophilia complicated by an inhibitor.
(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)
Please use this url to cite or link to this publication:
https://lup.lub.lu.se/record/160877
- author
- Astermark, Jan LU ; Donfield, Sharyne M ; Dimichele, Donna M ; Gringeri, Alessandro ; Gilbert, Steven A ; Waters, Jennifer and Berntorp, Erik LU
- organization
- publishing date
- 2007
- 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
- 2016-04-01 11:40:04
- date last changed
- 2022-05-14 01:49:40
@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}}, doi = {{10.1182/blood-2006-04-017988}}, volume = {{109}}, year = {{2007}}, }