- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00166309
The FEIBA NovoSeven Comparative Study
April 18, 2007 updated by: Skane University Hospital
FENOC: 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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Malmo, Sweden, SE-205 02
- Malmö University Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
2 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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-The hemostatic effect of treatment with a single dose of FEIBA with that of two doses of NovoSeven on joint hemorrhages after 6 hours.
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Secondary Outcome Measures
Outcome Measure |
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The hemostatic effect of treatment after 2, 12, 24 36, and 48 hours.
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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.
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The number of infusions required of each concentrate to stop the bleeding.
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The use of analgesics.
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Cost-efficacy, analyzed on the basis of clinical response.
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Correlation between thrombin generation in vitro with each concentrate and the in vivo clinical response.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Erik Berntorp, MD, PhD, Skane University Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2000
Study Completion (Actual)
June 1, 2005
Study Registration Dates
First Submitted
September 9, 2005
First Submitted That Met QC Criteria
September 9, 2005
First Posted (Estimate)
September 14, 2005
Study Record Updates
Last Update Posted (Estimate)
April 19, 2007
Last Update Submitted That Met QC Criteria
April 18, 2007
Last Verified
April 1, 2007
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- FENOC
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Severe Hemophilia A With an Inhibitor
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Christoph KönigsRoche Pharma AG; Chugai Pharma Germany GmbHRecruitingSevere Hemophilia A | Severe Hemophilia A With Inhibitor | Severe Hemophilia A Without InhibitorGermany
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Kathelijn FischerRadboud University Medical Center; University Medical Center Groningen; Maastricht... and other collaboratorsRecruitingAdolescent | Child | Hemophilia A With Inhibitor | Adult | Hemophilia A Without Inhibitor | Hemophilia A, SevereNetherlands
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Catalyst BiosciencesCompletedHemophilia A | Hemophilia B | Hemophilia A With Inhibitor | Hemophilia B With Inhibitor | Hemophilia A Without Inhibitor | Hemophilia B Without InhibitorBulgaria, Russian Federation
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American Thrombosis and Hemostasis NetworkTakeda; CSL Behring; OctapharmaCompletedHemophilia A | Hemophilia B | Hemophilia | Hemophilia A With Inhibitor | Haemophilia | Hemophilia B With Inhibitor | Haemophilia A Without Inhibitor | Haemophilia B Without InhibitorUnited States
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American Thrombosis and Hemostasis NetworkGenentech, Inc.Active, not recruitingHemophilia A With Inhibitor | Hemophilia B With Inhibitor | Haemophilia A Without Inhibitor | Haemophilia B Without InhibitorUnited States
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JW PharmaceuticalRecruitingHemophilia A With Inhibitor | Hemophilia A Without InhibitorKorea, Republic of
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Grifols Italia S.p.AThrombinoscopeUnknownSevere Hemophilia A With InhibitorItaly
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Suzhou Alphamab Co., Ltd.RecruitingHemophilia A With Inhibitor | Hemophilia B With InhibitorChina
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AryoGen Pharmed Co.CompletedHemophilia A With Inhibitor | Hemophilia B With InhibitorIran, Islamic Republic of
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Chia Tai Tianqing Pharmaceutical Group Co., Ltd.UnknownHemophilia A With Inhibitor | Hemophilia B With InhibitorChina
Clinical Trials on FEIBA and NovoSeven
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Sheba Medical CenterCompleted
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Oslo University HospitalCompletedHereditary Factor VIII Deficiency Disease With InhibitorNorway
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Emory UniversityOctapharmaRecruitingHemophilia AUnited States, Germany
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Hoffmann-La RocheChugai PharmaceuticalCompletedHemophilia AKorea, Republic of, United States, France, Germany, Italy, South Africa, Spain, Japan, United Kingdom, Poland, Taiwan, Australia, Costa Rica, New Zealand
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Chia Tai Tianqing Pharmaceutical Group Co., Ltd.UnknownHemophilia A With Inhibitor | Hemophilia B With InhibitorChina
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Medical University of ViennaCompleted
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AryoGen Pharmed Co.CompletedFactor VII DeficiencyIran, Islamic Republic of
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Children's Hospital Los AngelesTakedaActive, not recruitingHemophilia A With InhibitorUnited States
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Leiden University Medical CenterNovo Nordisk A/S; University of Oxford; Herlev Hospital; VU University of AmsterdamCompletedPost Partum HemorrhageNetherlands
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Mayo ClinicWithdrawn