The FEIBA NovoSeven Comparative Study

Severe Hemophilia A With an Inhibitor Clinical Trial

Official title:

FENOC: The FEIBA NovoSeven Comparative Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00166309
• Other study ID #: FENOC
• Status: Completed
• Phase: N/A
• First received: September 9, 2005
• Last updated: April 18, 2007
• Start date: July 2000
• Est. completion date: June 2005

Study information

• Verified date: April 2007
• Source: Skane University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 2005
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 2 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hemophilia A
• Severe Hemophilia A With an Inhibitor

Intervention

Drug:
• FEIBA and NovoSeven

Locations

Country	Name	City	State
Sweden	Malmo University Hospital	Malmo

Sponsors (1)

Lead Sponsor	Collaborator
Skane University Hospital

Country where clinical trial is conducted

Sweden, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	-The hemostatic effect of treatment with a single dose of FEIBA with that of two doses of NovoSeven on joint hemorrhages after 6 hours.
Secondary	The hemostatic effect of treatment after 2, 12, 24 36, and 48 hours.
Secondary	The difference in pain, rated using the 100 mm visual analog scale (VAS) before treatment and after 2 (before the second dose of NovoSeven, 6, 12, 24, 36, and 48 hours.
Secondary	The number of infusions required of each concentrate to stop the bleeding.
Secondary	The use of analgesics.
Secondary	Cost-efficacy, analyzed on the basis of clinical response.
Secondary	Correlation between thrombin generation in vitro with each concentrate and the in vivo clinical response.