Acquired Bleeding DisorderPhase 2NCT00154492
Use of NovoSeven® in Active Variceal Bleeding
A Phase 2 study testing activated recombinant human factor VII in people with Acquired Bleeding Disorder and Cirrhosis, run by Novo Nordisk A/S at 44 sites in 12 countries.
Trial summary
This trial is conducted in Asia and Europe. The trial is planned to investigate the effectiveness and safety of NovoSeven® in patients with advanced cirrhosis and active variceal bleeding. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Acquired Bleeding Disorder, Cirrhosis
- What is being tested?
- activated recombinant human factor VII
- How many people
- 265 participants
- Where
- 44 sitesin 12 countries
- Study dates
- Apr 2004to Aug 2006
- Phase
- Phase 2
- 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 18 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Variceal bleeding
Who cannot join
None listed.
Trial locations and contacts
44 sites in 12 countries.
44 sites in 12 countries
France13 sites
Novo Nordisk Investigational Site
Angers, 49033
Novo Nordisk Investigational Site
Caen, 14033
Novo Nordisk Investigational Site
Clichy, 92 188
Novo Nordisk Investigational Site
Grenoble, 38043
Novo Nordisk Investigational Site
Lille, 59037
Novo Nordisk Investigational Site
Limoges, 87042
Novo Nordisk Investigational Site
Marseille, 13385
Novo Nordisk Investigational Site
Nantes, 44093
Novo Nordisk Investigational Site
Nice, 06202
Novo Nordisk Investigational Site
Paris, 75012
Novo Nordisk Investigational Site
Paris, 75013
Novo Nordisk Investigational Site
Toulouse, 31059
Novo Nordisk Investigational Site
Villejuif, 94804
Spain8 sites
Novo Nordisk Investigational Site
Badalona, 08916
Novo Nordisk Investigational Site
Barcelona, 08003
Novo Nordisk Investigational Site
Barcelona, 08025
Novo Nordisk Investigational Site
Barcelona, 08036
Novo Nordisk Investigational Site
Córdoba, 14004
Novo Nordisk Investigational Site
Madrid, 28007
Novo Nordisk Investigational Site
Madrid, 28034
Novo Nordisk Investigational Site
Majadahonda, 28222
Germany6 sites
Novo Nordisk Investigational Site
Berlin, 13353
Novo Nordisk Investigational Site
Heidelberg, 69120
Novo Nordisk Investigational Site
Leipzig, 04103
Novo Nordisk Investigational Site
München, 81377
Novo Nordisk Investigational Site
Münster, 48145
Novo Nordisk Investigational Site
Ulm, 89081
Czechia3 sites
Novo Nordisk Investigational Site
Olomouc, 77520
Novo Nordisk Investigational Site
Prague, 12821
Novo Nordisk Investigational Site
Prague, 140 21
Italy3 sites
Novo Nordisk Investigational Site
Milan, 20162
Novo Nordisk Investigational Site
Naples, 80131
Novo Nordisk Investigational Site
Palermo, 30146
Poland3 sites
Novo Nordisk Investigational Site
Katowice, 40-752
Novo Nordisk Investigational Site
Krakow, 31-826
Novo Nordisk Investigational Site
Warsaw, 02-097
United Kingdom3 sites
Novo Nordisk Investigational Site
Leeds, LS9 7TF
Novo Nordisk Investigational Site
London, WC1 6HX
Novo Nordisk Investigational Site
Oxford, OX3 9DU
About this study
Official title: Effectiveness and Safety of Use of NovoSeven® in the Treatment of Active Variceal Bleeding in Patients With Advanced Cirrhosis
This trial is conducted in Asia and Europe. The trial is planned to investigate the effectiveness and safety of NovoSeven® in patients with advanced cirrhosis and active variceal bleeding.
- Conditions
- Acquired Bleeding Disorder, Cirrhosis
- Being tested
- activated recombinant human factor VII
- Keywords
- Active variceal bleeding in patients with advanced cirrhosis
- Medical subject headings
- Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
activated recombinant human factor VIIDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment failure
Measured: Within 5 days after first trial product administration
Secondary outcomes (3)
Mortality
Rebleeding
Control of acute bleeding
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startApr 2004
- Primary completionAug 2006
- Study completionAug 2006
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 Acquired Bleeding DisorderStudies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 265 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Global Clinical Registry (GCR, 1452), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00154492
- Sponsor's protocol ID
- F7LIVER-1533
- Status last verified
- Jan 2017
- First submitted
- 9 Sep 2005
- Last updated
- 13 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Hsia CC, Chin-Yee IH, McAlister VC. Use of recombinant activated factor VII in patients without hemophilia: a meta-analysis of randomized control trials. Ann Surg. 2008 Jul;248(1):61-8. doi: 10.1097/SLA.0b013e318176c4ec.
PubMed 18580208
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Safety of Use of NovoSeven® in the Treatment of Active Variceal Bleeding in Patients With Advanced Cirrhosis
- ClinicalTrials.gov ID
- NCT00154492
- Acronym / sponsor ID
- F7LIVER-1533
- Conditions
- Acquired Bleeding Disorder, Cirrhosis
- Keywords
- Active variceal bleeding in patients with advanced cirrhosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 265 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Apr 2004
- Primary completion
- Aug 2006 (actual)
- Study completion
- Aug 2006 (actual)
- First posted
- 12 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.
This trial is conducted in Asia and Europe. The trial is planned to investigate the effectiveness and safety of NovoSeven® in patients with advanced cirrhosis and active variceal bleeding.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Variceal bleeding
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| activated recombinant human factor VII | Drug | – |
Primary outcome
Treatment failure
Time frame: Within 5 days after first trial product administration
3 secondary outcomes
Mortality
Rebleeding
Control of acute bleeding
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 13 Jan 2017.
- Results publication: PubMed 18580208Hsia CC, Chin-Yee IH, McAlister VC. Use of recombinant activated factor VII in patients without hemophilia: a meta-analysis of randomized control trials. Ann Surg. 2008 Jul;248(1):61-8. doi: 10.1097/SLA.0b013e318176c4ec.
- Clinical Trials at Novo NordiskLink provided by the sponsor.
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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.
Global Clinical Registry (GCR, 1452) study director
Novo Nordisk A/S
44 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing activated recombinant human factor VII in people with Acquired Bleeding Disorder and Cirrhosis, run by Novo Nordisk A/S at 44 sites in 12 countries.
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 1 inclusion and 0 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 13 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 44 sites in France, Spain, Germany, Czechia, Italy and 7 more countries. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Treatment failure (time frame: Within 5 days after first trial product administration). 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 NCT00154492, 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 13 Jan 2017.