Congenital Bleeding DisorderPhase 4NCT01561391
Safety and Efficacy of Activated Recombinant Human Factor VII in Haemophilia Patients With Inhibitors During and After Major Surgery
A Phase 4 study testing activated recombinant human factor VII, factor IX and factor VIII in people with Congenital Bleeding Disorder and Haemophilia A With Inhibitors, run by Novo Nordisk A/S at 14 sites in United States.
Trial summary
This trial is conducted in North America. The aim of this trial is to compare the safety and efficacy of activated recombinant human factor VII in patients with haemophilia A or B undergoing major surgical procedures. Read more about this study
- Who is it for?
- Ages 5 years and older
- Conditions the study is for
- Congenital Bleeding Disorder, Haemophilia A With Inhibitors, Haemophilia B With Inhibitors
- What is being tested?
- activated recombinant human factor VII, factor IX and factor VIII
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 14 sitesUnited States
- Study dates
- Apr 1998to May 2004
- Phase
- Phase 4
- 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 5 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Have haemophilia A or B with inhibitors to factor VIII or IX, respectively
- Have had a historical inhibitor level of at least five Bethesda units or have had an inadequate haemostatic response to 250 U/kg of factor VIII or IX or have had an inadequate response to FEIBA
- Require pre-planned major surgery in hospital
Who cannot join
- Have participated in or have been treated with any investigational drug other than activated recombinant human factor VII within the last thirty days
- Have been treated with any haemostatic agent, including rFVIIa, within 48 hours of preoperative dose
- Have any haemostatic disorder other than haemophilia
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United States14 sites
Novo Nordisk Investigational Site
Albuquerque, New Mexico, 87106
Novo Nordisk Investigational Site
Boston, Massachusetts, 02115
Novo Nordisk Investigational Site
Chapel Hill, North Carolina, 27599-7220
Novo Nordisk Investigational Site
Chicago, Illinois, 60611
Novo Nordisk Investigational Site
Chicago, Illinois, 60612
Novo Nordisk Investigational Site
Hershey, Pennsylvania, 17033
Novo Nordisk Investigational Site
Houston, Texas, 77030
Novo Nordisk Investigational Site
Los Angeles, California, 90027
Novo Nordisk Investigational Site
New Brunswick, New Jersey, 08903
Novo Nordisk Investigational Site
New Orleans, Louisiana, 70112
Novo Nordisk Investigational Site
New York, New York, 10029-6574
Novo Nordisk Investigational Site
Philadelphia, Pennsylvania, 19104
Novo Nordisk Investigational Site
Philadelphia, Pennsylvania, 19107
Novo Nordisk Investigational Site
Rochester, Minnesota, 55905
About this study
Official title: An Open-Label, Randomized, Parallel, Multicenter Trial Comparing the Safety and Efficacy of rFVIIa When Administered as i.v. Bolus or i.v. Continuous Infusion to Hemophiliacs With Inhibitors During and After Major Surgery
This trial is conducted in North America. The aim of this trial is to compare the safety and efficacy of activated recombinant human factor VII in patients with haemophilia A or B undergoing major surgical procedures.
- Conditions
- Congenital Bleeding Disorder, Haemophilia A With Inhibitors, Haemophilia B With Inhibitors
- Being tested
- activated recombinant human factor VII, factor IX, factor VIII
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
activated recombinant human factor VIIDrug
Infused continuously at 50 mcg/kg/hr through Day 5 then at 25 mcg/kg/hr on Days 6 to10.
activated recombinant human factor VIIDrug
Injected every 2 hours during surgery through Day 5, then every 4 hours for Days 6 to 10.
factor IXOther
Patients with haemophilia A or B without inhibitors undergoing similar surgery were treated in accordance with local standard of care per physician's orders.
factor VIIIDrug
Patients with haemophilia A or B without inhibitors undergoing similar surgery were treated in accordance with local standard of care per physician's orders.
| Study group | Role | What they receive |
|---|---|---|
| Continuous infusion | Experimental | Not described Receives: Drug: activated recombinant human factor VII |
| Bolus injection | Experimental | Not described Receives: Drug: activated recombinant human factor VII |
| Control | Experimental | Not described Receives: Other: factor IX; Drug: factor VIII |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence and maintenance of haemostasis
Changes in FVII:C (Factor VII clotting activity) levels following administration of activated recombinant human factor VII
Secondary outcomes (2)
Adverse Events
Changes in coagulation-related parameters
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 1998
- Primary completionMay 2004
- Study completionMay 2004
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 Congenital 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 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
- NCT01561391
- Sponsor's protocol ID
- F7HAEM/USA/4/USA
- Status last verified
- Jan 2017
- First submitted
- 21 Mar 2012
- Last updated
- 29 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Pruthi RK, Mathew P, Valentino LA, Sumner MJ, Seremetis S, Hoots WK; NovoSeven in Surgery Study Investigators. Haemostatic efficacy and safety of bolus and continuous infusion of recombinant factor VIIa are comparable in haemophilia patients with inhibitors undergoing major surgery. Results from an open-label, randomized, multicenter trial. Thromb Haemost. 2007 Oct;98(4):726-32.
PubMed 17938794
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Randomized, Parallel, Multicenter Trial Comparing the Safety and Efficacy of rFVIIa When Administered as i.v. Bolus or i.v. Continuous Infusion to Hemophiliacs With Inhibitors During and After Major Surgery
- ClinicalTrials.gov ID
- NCT01561391
- Acronym / sponsor ID
- F7HAEM/USA/4/USA
- Conditions
- Congenital Bleeding Disorder, Haemophilia A With Inhibitors, Haemophilia B With Inhibitors
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Apr 1998
- Primary completion
- May 2004 (actual)
- Study completion
- May 2004 (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 North America. The aim of this trial is to compare the safety and efficacy of activated recombinant human factor VII in patients with haemophilia A or B undergoing major surgical procedures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Continuous infusion | Experimental | Drug: activated recombinant human factor VII |
| Bolus injection | Experimental | Drug: activated recombinant human factor VII |
| Control | Experimental | Other: factor IX, Drug: factor VIII |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Have haemophilia A or B with inhibitors to factor VIII or IX, respectively
- Have had a historical inhibitor level of at least five Bethesda units or have had an inadequate haemostatic response to 250 U/kg of factor VIII or IX or have had an inadequate response to FEIBA
- Require pre-planned major surgery in hospital
Key exclusion criteria (3 listed)
- Have participated in or have been treated with any investigational drug other than activated recombinant human factor VII within the last thirty days
- Have been treated with any haemostatic agent, including rFVIIa, within 48 hours of preoperative dose
- Have any haemostatic disorder other than haemophilia
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 VIIInfused continuously at 50 mcg/kg/hr through Day 5 then at 25 mcg/kg/hr on Days 6 to10. | Drug | Continuous infusion |
| activated recombinant human factor VIIInjected every 2 hours during surgery through Day 5, then every 4 hours for Days 6 to 10. | Drug | Bolus injection |
| factor IXPatients with haemophilia A or B without inhibitors undergoing similar surgery were treated in accordance with local standard of care per physician's orders. | Other | Control |
| factor VIIIPatients with haemophilia A or B without inhibitors undergoing similar surgery were treated in accordance with local standard of care per physician's orders. | Drug | Control |
Primary outcome
Presence and maintenance of haemostasis
Changes in FVII:C (Factor VII clotting activity) levels following administration of activated recombinant human factor VII
2 secondary outcomes
Adverse Events
Changes in coagulation-related parameters
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 29 Dec 2023.
- Results publication: PubMed 17938794Pruthi RK, Mathew P, Valentino LA, Sumner MJ, Seremetis S, Hoots WK; NovoSeven in Surgery Study Investigators. Haemostatic efficacy and safety of bolus and continuous infusion of recombinant factor VIIa are comparable in haemophilia patients with inhibitors undergoing major surgery. Results from an open-label, randomized, multicenter trial. Thromb Haemost. 2007 Oct;98(4):726-32.
- 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
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing activated recombinant human factor VII, factor IX and factor VIII in people with Congenital Bleeding Disorder and Haemophilia A With Inhibitors, run by Novo Nordisk A/S at 14 sites in United States.
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 3 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 29 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Presence and maintenance of haemostasis. The study lists 2 primary outcomes in all. 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 NCT01561391, 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 29 Dec 2023.