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Completed

NCT Number: NCT00166309

The FEIBA NovoSeven Comparative Study

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.

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Key information

Conditions

Severe Hemophilia A With an Inhibitor Blood Coagulation Disorders Blood Coagulation Disorders, Inherited Coagulation Protein Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemophilia A Hemorrhagic Disorders

Age range

2 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Malmo University Hospital

Malmö, SE-205 02, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

FEIBA and NovoSeven

Drug

Primary outcomes

  1. -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 outcomes

  1. The hemostatic effect of treatment after 2, 12, 24 36, and 48 hours.

  2. 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.

  3. The number of infusions required of each concentrate to stop the bleeding.

  4. The use of analgesics.

  5. Cost-efficacy, analyzed on the basis of clinical response.

  6. Correlation between thrombin generation in vitro with each concentrate and the in vivo clinical response.

Sponsors and collaborators

Lead sponsor

Skane University Hospital

Other

Registry information

Official study title

FENOC: The FEIBA NovoSeven Comparative Study

Important dates

Study start
2000
Study completion
2005
First posted
Sep 14, 2005
Registry last updated
Apr 19, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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