The FEIBA NovoSeven Comparative Study

• Status: Completed
• Trial end date: 2005-06-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Skane University Hospital

Criteria

Inclusion Criteria:

• Congenital hemophilia A with an inhibitor and the need for by-passing agents in the case of joint bleeding.

• An expected bleeding frequency of >=3 joint bleeds per year.

• Informed consent given.

• Age of two or older.

Exclusion Criteria:

• Other congenital and acquired bleeding disorders.

• Symptomatic liver disease.

• Life expectancy <12 months.