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The FEIBA NovoSeven Comparative Study

Primary Purpose

Severe Hemophilia A With an Inhibitor

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
FEIBA and NovoSeven
Sponsored by
Skane University Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Severe Hemophilia A With an Inhibitor focused on measuring Hemophilia A, Inhibitors

Eligibility Criteria

2 Years - undefined (Child, Adult, Older Adult)MaleDoes not accept 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: Other congenital and acquired bleeding disorders. Symptomatic liver disease. Life expectancy <12 months.

Sites / Locations

  • Malmo University Hospital

Outcomes

Primary Outcome Measures

-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 Outcome Measures

The hemostatic effect of treatment after 2, 12, 24 36, and 48 hours.
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.
The number of infusions required of each concentrate to stop the bleeding.
The use of analgesics.
Cost-efficacy, analyzed on the basis of clinical response.
Correlation between thrombin generation in vitro with each concentrate and the in vivo clinical response.

Full Information

First Posted
September 9, 2005
Last Updated
April 18, 2007
Sponsor
Skane University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00166309
Brief Title
The FEIBA NovoSeven Comparative Study
Official Title
FENOC: The FEIBA NovoSeven Comparative Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2007
Overall Recruitment Status
Completed
Study Start Date
July 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Skane University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Severe Hemophilia A With an Inhibitor
Keywords
Hemophilia A, Inhibitors

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
FEIBA and NovoSeven
Primary Outcome Measure Information:
Title
-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 Outcome Measure Information:
Title
The hemostatic effect of treatment after 2, 12, 24 36, and 48 hours.
Title
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.
Title
The number of infusions required of each concentrate to stop the bleeding.
Title
The use of analgesics.
Title
Cost-efficacy, analyzed on the basis of clinical response.
Title
Correlation between thrombin generation in vitro with each concentrate and the in vivo clinical response.

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
2 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erik Berntorp, MD, PhD
Organizational Affiliation
Skane University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Malmo University Hospital
City
Malmo
ZIP/Postal Code
SE-205 02
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
16990605
Citation
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.
Results Reference
result

Learn more about this trial

The FEIBA NovoSeven Comparative Study

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