Severe Hemophilia A With an InhibitorNCT00166309
The FEIBA NovoSeven Comparative Study
A study testing FEIBA and NovoSeven in people with Severe Hemophilia A With an Inhibitor, run by Skane University Hospital at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 years and older, men only
- Conditions the study is for
- Severe Hemophilia A With an Inhibitor
- What is being tested?
- FEIBA and NovoSeven
- How many people
- 60 participants
- Where
- 1 siteSweden
- Study dates
- Jul 2000to Jun 2005
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 years and older
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Other congenital and acquired bleeding disorders.
- Symptomatic liver disease.
- Life expectancy <12 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Severe Hemophilia A With an Inhibitor
- Being tested
- FEIBA and NovoSeven
- Keywords
- Hemophilia A, Inhibitors
- Medical subject headings
- Hemophilia A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FEIBA and NovoSevenDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
-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 (6)
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2005 (estimated)
- Study startJul 2000
- Study completionJun 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Severe Hemophilia A With an InhibitorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 60 participants
Sponsor and investigators
- Lead sponsor
- Skane University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Erik Berntorp, MD, PhD, Principal investigator, Skane University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00166309
- Sponsor's protocol ID
- FENOC
- Status last verified
- Apr 2007
- First submitted
- 9 Sep 2005
- Last updated
- 19 Apr 2007
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 16990605
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FENOC: The FEIBA NovoSeven Comparative Study
- ClinicalTrials.gov ID
- NCT00166309
- Acronym / sponsor ID
- FENOC
- Conditions
- Severe Hemophilia A With an Inhibitor
- Keywords
- Hemophilia A, Inhibitors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants
- Lead sponsor
- Skane University HospitalUniversity, hospital or other
- Study start
- Jul 2000
- Study completion
- Jun 2005 (actual)
- First posted
- 14 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 2 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- Other congenital and acquired bleeding disorders.
- Symptomatic liver disease.
- Life expectancy <12 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FEIBA and NovoSeven | Drug | – |
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.
6 secondary outcomes
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2007.
- Results publication: PubMed 16990605Astermark 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erik Berntorp, MD, PhD principal investigator
Skane University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FEIBA and NovoSeven in people with Severe Hemophilia A With an Inhibitor, run by Skane University Hospital at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Apr 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
-The hemostatic effect of treatment with a single dose of FEIBA with that of two doses of NovoSeven on joint hemorrhages after 6 hours.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00166309, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2007.