The FEIBA NovoSeven Comparative Study

Skane University Hospital

Status

Completed

Conditions

Severe Hemophilia A With an Inhibitor

Treatments

Drug: FEIBA and NovoSeven

Study type

Interventional

Funder types

Other

Identifiers

NCT00166309

FENOC

Details and patient eligibility

About

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.

Full description

The incidence of inhibitors among people with severe hemophilia A has been documented as approximately 20-30% in several prospective studies. In such patients acute hemorrhages frequently occur and profoundly jeopardize health, with subsequent development of arthropathy. A common way of treating such bleeding episodes is to use bypassing agents. Among these agents the prothrombin complex concentrate FEIBA has been widely used for many years. More recently, recombinant factor VIIa (NovoSeven) has been added to the therapeutic options. While both products have been found effective in treating hemorrhages, the number of injections given for a bleeding episode has ranged widely, and it is so far unknown whether one of the products might have a better effect in certain patients.

Sex

Male

Ages

2+ years old

Volunteers

No Healthy Volunteers

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