The FEIBA NovoSeven Comparative Study

This study has been completed.
Sponsor:
Information provided by:
Skane University Hospital
ClinicalTrials.gov Identifier:
NCT00166309
First received: September 9, 2005
Last updated: April 18, 2007
Last verified: April 2007
  Purpose

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.


Condition Intervention
Severe Hemophilia A With an Inhibitor
Drug: FEIBA and NovoSeven

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: FENOC: The FEIBA NovoSeven Comparative Study

Resource links provided by NLM:


Further study details as provided by Skane University Hospital:

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.

Estimated Enrollment: 60
Study Start Date: July 2000
Study Completion Date: June 2005
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

Ages Eligible for Study:   2 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00166309

Locations
Sweden
Malmo University Hospital
Malmo, Sweden, SE-205 02
Sponsors and Collaborators
Skane University Hospital
Investigators
Principal Investigator: Erik Berntorp, MD, PhD Malmo University Hospital
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00166309     History of Changes
Other Study ID Numbers: FENOC
Study First Received: September 9, 2005
Last Updated: April 18, 2007
Health Authority: Sweden: Medical Products Agency

Keywords provided by Skane University Hospital:
Hemophilia A
Inhibitors

Additional relevant MeSH terms:
Hemophilia A
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn

ClinicalTrials.gov processed this record on July 29, 2014