The FEIBA NovoSeven Comparative Study
Information source: Malmö University Hospital
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Severe Hemophilia A With an Inhibitor
Intervention: FEIBA and NovoSeven (Drug)
Phase: N/A
Status: Completed
Sponsored by: Malmö University Hospital Official(s) and/or principal investigator(s):
Erik Berntorp, MD, PhD, Principal Investigator, Affiliation: Malmo University Hospital
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.
Clinical Details
Official title: FENOC: The FEIBA NovoSeven Comparative Study
Study design: Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Efficacy Study
Primary outcome: -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: 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.
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.
Eligibility
Minimum age: 2 Years.
Maximum age: N/A.
Gender(s): Male.
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.
Locations and Contacts
Malmo University Hospital, Malmo SE-205 02, Sweden
Additional Information
Starting date: July 2000
Ending date: June 2005
Last updated: April 18, 2007
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