Acquired Bleeding DisorderPhase 2NCT01562158
Efficacy and Safety of Activated Recombinant Human Factor VII in Treatment of Bleeding in Patients Following Allogeneic Stem Cell Transplantation
A Phase 2 study testing standard therapy and activated recombinant human factor VII in people with Acquired Bleeding Disorder and Bleeding During/Following Surgery, run by Novo Nordisk A/S at 46 sites in 16 countries.
Trial summary
This trial is conducted in Asia, Europe and Oceania. The aim of this trial is to evaluate the efficacy of placebo and activated recombinant human factor VII in patients having undergone allogeneic or autologous stem cell transplantation. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Acquired Bleeding Disorder, Bleeding During/Following Surgery
- What is being tested?
- standard therapy and activated recombinant human factor VII
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 46 sitesin 16 countries
- Study dates
- Apr 2001to Oct 2003
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients who have undergone allogeneic or autologous stem cell transplantation
Who cannot join
- Known or suspected allergy to trial product
- Participation in other trials with unapproved drugs or trials with equal or similar objective
Trial locations and contacts
46 sites in 16 countries.
46 sites in 16 countries
Germany9 sites
Novo Nordisk Investigational Site
Cologne, 50924
Novo Nordisk Investigational Site
Dresden, 01307
Novo Nordisk Investigational Site
Hamburg, 20246
Novo Nordisk Investigational Site
Hanover, 30625
Novo Nordisk Investigational Site
Idar-Oberstein, 55743
Novo Nordisk Investigational Site
München, 81377
Novo Nordisk Investigational Site
Regensburg, 93042
Novo Nordisk Investigational Site
Tübingen, 72076
Novo Nordisk Investigational Site
Wiesbaden, 65191
Poland7 sites
Novo Nordisk Investigational Site
Gdansk, 80-952
Novo Nordisk Investigational Site
Katowice, 40-029
Novo Nordisk Investigational Site
Poznan, 60-569
Novo Nordisk Investigational Site
Warsaw, 00-909
Novo Nordisk Investigational Site
Warsaw, 02-097
Novo Nordisk Investigational Site
Wroclaw, 50-345
Novo Nordisk Investigational Site
Wroclaw, 53-439
Italy5 sites
Novo Nordisk Investigational Site
Florence, 50134
Novo Nordisk Investigational Site
Genova, 16132
Novo Nordisk Investigational Site
Pesaro, 61100
Novo Nordisk Investigational Site
Rome, 00144
Novo Nordisk Investigational Site
Udine, 33100
Australia3 sites
Novo Nordisk Investigational Site
Herston, 4029
Novo Nordisk Investigational Site
Parkville, 3050
Novo Nordisk Investigational Site
Westmead, 2145
France3 sites
Novo Nordisk Investigational Site
Besançon, 25030
Novo Nordisk Investigational Site
Lille, 59037
Novo Nordisk Investigational Site
Tours, 37044
Spain3 sites
Novo Nordisk Investigational Site
Barcelona, 08036
Novo Nordisk Investigational Site
Santander, 39008
Novo Nordisk Investigational Site
Valencia, 46026
Sweden3 sites
Novo Nordisk Investigational Site
Gothenburg, 413 45
Novo Nordisk Investigational Site
Stockholm, 141 86
Novo Nordisk Investigational Site
Uppsala, 751 85
Israel2 sites
Novo Nordisk Investigational Site
Haifa, 31096
Novo Nordisk Investigational Site
Jerusalem, 91120
Switzerland2 sites
Novo Nordisk Investigational Site
Basel, 4031
Novo Nordisk Investigational Site
Zurich, 8091
Thailand2 sites
Novo Nordisk Investigational Site
Bangkok, 10330
Novo Nordisk Investigational Site
Bangkok
United Kingdom2 sites
Novo Nordisk Investigational Site
London, W12 OHS
Novo Nordisk Investigational Site
Manchester, M20 4BX
United States1 site
Novo Nordisk Investigational Site
Chapel Hill, North Carolina, 27599-7035
About this study
Official title: A Multi-centre, Randomised, Double-blind, Parallel Groups, Placebocontrolled Trial on Efficacy and Safety of Activated Recombinant Factor VII (rFVIIa/NovoSeven®) in Treatment of Bleeding in Patients Following Stem Cell Transplantation (SCT)
This trial is conducted in Asia, Europe and Oceania. The aim of this trial is to evaluate the efficacy of placebo and activated recombinant human factor VII in patients having undergone allogeneic or autologous stem cell transplantation.
- Being tested
- standard therapy, activated recombinant human factor VII, placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standard therapyProcedure or surgery
Standard treatment of bleeding
activated recombinant human factor VIIDrug
Two days repeated treatment regimen - low dose administered i.v. (into the vein)
activated recombinant human factor VIIDrug
Two days repeated treatment regimen - medium dose administered i.v. (into the vein)
activated recombinant human factor VIIDrug
Two days repeated treatment regimen - high dose administered i.v. (into the vein)
placeboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Procedure: standard therapy; Drug: placebo |
| Low dose | Experimental | Not described Receives: Procedure: standard therapy; Drug: activated recombinant human factor VII |
| Medium dose | Experimental | Not described Receives: Procedure: standard therapy; Drug: activated recombinant human factor VII |
| High dose | Experimental | Not described Receives: Procedure: standard therapy; Drug: activated recombinant human factor VII |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect on bleeding, defined as change in bleeding score
Secondary outcomes (3)
Transfusion requirements
Bleeding evaluation
Adverse events
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2012 (estimated)
- Study startApr 2001
- Primary completionOct 2003
- Study completionOct 2003
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
- 100 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
- NCT01562158
- Sponsor's protocol ID
- F7BMT-1360
- Status last verified
- Jan 2017
- First submitted
- 22 Mar 2012
- Last updated
- 11 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Pihusch M, Bacigalupo A, Szer J, von Depka Prondzinski M, Gaspar-Blaudschun B, Hyveled L, Brenner B; F7BMT-1360 Trial Investigators. Recombinant activated factor VII in treatment of bleeding complications following hematopoietic stem cell transplantation. J Thromb Haemost. 2005 Sep;3(9):1935-44. doi: 10.1111/j.1538-7836.2005.01523.x.
PubMed 16102099
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-centre, Randomised, Double-blind, Parallel Groups, Placebocontrolled Trial on Efficacy and Safety of Activated Recombinant Factor VII (rFVIIa/NovoSeven®) in Treatment of Bleeding in Patients Following Stem Cell Transplantation (SCT)
- ClinicalTrials.gov ID
- NCT01562158
- Acronym / sponsor ID
- F7BMT-1360
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Apr 2001
- Primary completion
- Oct 2003 (actual)
- Study completion
- Oct 2003 (actual)
- First posted
- 23 Mar 2012 (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, Europe and Oceania. The aim of this trial is to evaluate the efficacy of placebo and activated recombinant human factor VII in patients having undergone allogeneic or autologous stem cell transplantation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Procedure: standard therapy, Drug: placebo |
| Low dose | Experimental | Procedure: standard therapy, Drug: activated recombinant human factor VII |
| Medium dose | Experimental | Procedure: standard therapy, Drug: activated recombinant human factor VII |
| High dose | Experimental | Procedure: standard therapy, Drug: activated recombinant human factor VII |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who have undergone allogeneic or autologous stem cell transplantation
Key exclusion criteria (2 listed)
- Known or suspected allergy to trial product
- Participation in other trials with unapproved drugs or trials with equal or similar objective
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 |
|---|---|---|
| standard therapyStandard treatment of bleeding | Procedure or surgery | High dose, Low dose, Medium dose, Placebo |
| activated recombinant human factor VIITwo days repeated treatment regimen - low dose administered i.v. (into the vein) | Drug | Low dose |
| activated recombinant human factor VIITwo days repeated treatment regimen - medium dose administered i.v. (into the vein) | Drug | Medium dose |
| activated recombinant human factor VIITwo days repeated treatment regimen - high dose administered i.v. (into the vein) | Drug | High dose |
| placeboPlacebo | Drug | Placebo |
Primary outcome
Effect on bleeding, defined as change in bleeding score
3 secondary outcomes
Transfusion requirements
Bleeding evaluation
Adverse events
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 11 Jan 2017.
- Results publication: PubMed 16102099Pihusch M, Bacigalupo A, Szer J, von Depka Prondzinski M, Gaspar-Blaudschun B, Hyveled L, Brenner B; F7BMT-1360 Trial Investigators. Recombinant activated factor VII in treatment of bleeding complications following hematopoietic stem cell transplantation. J Thromb Haemost. 2005 Sep;3(9):1935-44. doi: 10.1111/j.1538-7836.2005.01523.x.
- Clinical Trials at Novo NordiskLink provided by the sponsor.
Related trials for Acquired Bleeding Disorder
RecruitingObservational study
Longitudinal Cohort of Thrombosis and Hemostasis Diseases
Immune Thrombocytopenia, Thrombotic Thrombocytopenic Purpura
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
46 sites in 16 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing standard therapy and activated recombinant human factor VII in people with Acquired Bleeding Disorder and Bleeding During/Following Surgery, run by Novo Nordisk A/S at 46 sites in 16 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 2 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 11 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 46 sites in Germany, Poland, Italy, Australia, France and 11 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. Some participants in this study may receive a placebo. 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?
Effect on bleeding, defined as change in bleeding score. 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 NCT01562158, 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 11 Jan 2017; AzTrials last refreshed its copy on 7 Nov 2026.