The FEIBA NovoSeven Comparative Study

Summary

FENOC is a prospective, open-label, randomized, cross-over, multi-center study to investigate and compare the hemostatic effect and cost-efficacy of two different by-passing agents in the treatment of joint hemorrhages in subjects with severe hemophilia A and inhibitors. The study is designed as a clinical equivalency trial.

Timeline

Start

2000-07

Primary completion

—

Completion

2005-06

Outcome

Missed primary endpoint

paper The criterion for declaring the 2 products equivalent at 6 hours was not met; PMID 16990605 ↗

Publications

• Results Astermark J, Donfield SM, DiMichele DM, Gringeri A, Gilbert SA, Waters J, Berntorp E; FENOC Study Group. A randomized comparison of bypassing agents in hemophilia complicated by an inhibitor: the FEIBA NovoSeven Comparative (FENOC) Study. Blood. 2007 Jan 15;109(2):546-51. doi: 10.1182/blood-2006-04-017988. Epub 2006 Sep 21.

Drugs

Indications