The FEIBA NovoSeven Comparative Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-07-31

Study Completion Date

2005-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Severe Hemophilia A With an Inhibitor

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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FEIBA and NovoSeven

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

2 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Principal Investigators

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Erik Berntorp, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Skane University Hospital

Locations

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Malmo University Hospital

Malmo, , Sweden

Site Status

Countries

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Sweden

References

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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.

Reference Type RESULT

PMID: 16990605 (View on PubMed)

Other Identifiers

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FENOC

Identifier Type: -

Identifier Source: org_study_id