HaemostasisPhase 1NCT01561937
Use of Activated Recombinant Human Factor VII to Reduce Bleeding Caused by Warfarin Treatment
A Phase 1 study testing warfarin and eptacog alfa (activated) in people with Haemostasis and Healthy, run by Novo Nordisk A/S at 1 site in United States.
Trial summary
This trial is conducted in the United States of America (USA). The aim of this trial is to evaluate the efficacy of activated recombinant human factor VII to mitigate experimentally-induced bleeding in healthy volunteers treated with warfarin to reach a targeted INR (International Normalization Ratio). Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Haemostasis, Healthy
- What is being tested?
- warfarin and eptacog alfa (activated)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 127 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2007to Jul 2008
- Phase
- Phase 1
- 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 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- INR below or equal to 1.2
Who cannot join
- The receipt of any investigational drug within 1 month prior to this trial
- Use of anticoagulation therapy-defined as vitamin K antagonists, platelet antagonists, heparin (or low molecular weight heparin), aspirin or NSAIDs (Non-Steroidal Anti-Inflammatory Drug) within 14 days prior to trial
- African-American race
- Weight above 160 kg
- Supplemental Vitamin K use
Trial locations and contacts
1 site in 1 country.
United States1 site
Novo Nordisk Investigational Site
Overland Park, Kansas, 66211
About this study
Official title: Use of Recombinant FVIIa to Mitigate Warfarin Anticoagulation Therapy-Mediated Bleeding in a Single Centre, Randomized, Placebo-controlled, Double-blind Clinical Trial
This trial is conducted in the United States of America (USA). The aim of this trial is to evaluate the efficacy of activated recombinant human factor VII to mitigate experimentally-induced bleeding in healthy volunteers treated with warfarin to reach a targeted INR (International Normalization Ratio).
- Conditions
- Haemostasis, Healthy
- Being tested
- warfarin, eptacog alfa (activated), placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
warfarinDrug
After a baseline punch biopsy (B0), warfarin is administered over a period of approximately 7-14 days. Dose is adjusted individually to achieve INR target. Once a stable INR is achieved, a second biopsy (B1) will be performed
eptacog alfa (activated)Drug
Also called activated recombinant human factor VII
If the subject is eligible to continue in trial part B, trial drug will be administered i.v. as a slow bolus injection over 2 to 5 minutes in five different doses followed by two biopsies (B2) and (B3) 15 minutes and 5 hours and 15 minutes, respectively, after trial drug administration
placeboDrug
If the subject is eligible to continue in trial part B, trial drug will be administered i.v. as a slow bolus injection over 2 to 5 minutes in five different doses followed by two biopsies (B2) and (B3) 15 minutes and 5 hours and 15 minutes, respectively, after trial drug administration
| Study group | Role | What they receive |
|---|---|---|
| Pre-warfarin treatment (trial part A) | Experimental | Not described Receives: Drug: warfarin |
| Post-warfarin treatment (trial part B) | Experimental | Not described Receives: Drug: eptacog alfa (activated); Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bleeding duration measured in minutes after biopsies in trial part A
Measured: From onset of bleeding till the end of the bleeding
Bleeding duration measured in minutes after biopsy B1 in trial part B
Measured: From onset of bleeding till the end of the bleeding
Secondary outcomes (8)
Blood volume reported in millilitres after biopsies in trial part A
Measured: From onset of bleeding till the end of the bleeding
Blood volume reported in millilitres after biopsy B1 in trial part B
Measured: From onset of bleeding till the end of the bleeding
Adverse events, including thrombotic events
Measured: From day 0 to days 14-28
Change in coagulation-related parameters after biopsy B1
Measured: From baseline to 3 hours after B1
Change in coagulation-related parameters after biopsy B2
Measured: From baseline to 3 hours after B2
Change in coagulation-related parameters after biopsy B3
Measured: From baseline to 3 hours after B3
Clot dynamics: R in minutes (trial part B)
Measured: Time to onset of clot formation
Clot dynamics: K in minutes (trial part B)
Measured: Time to achieve 20mm clot strength
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 startJan 2007
- Primary completionJul 2008
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HaemostasisStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 127 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
- NCT01561937
- Sponsor's protocol ID
- F7HAEM-1825
- Status last verified
- Nov 2016
- First submitted
- 21 Mar 2012
- Last updated
- 25 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Recombinant FVIIa to Mitigate Warfarin Anticoagulation Therapy-Mediated Bleeding in a Single Centre, Randomized, Placebo-controlled, Double-blind Clinical Trial
- ClinicalTrials.gov ID
- NCT01561937
- Acronym / sponsor ID
- F7HAEM-1825
- Conditions
- Haemostasis, Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 127 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Jan 2007
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (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 the United States of America (USA). The aim of this trial is to evaluate the efficacy of activated recombinant human factor VII to mitigate experimentally-induced bleeding in healthy volunteers treated with warfarin to reach a targeted INR (International Normalization Ratio).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre-warfarin treatment (trial part A) | Experimental | Drug: warfarin |
| Post-warfarin treatment (trial part B) | Experimental | Drug: eptacog alfa (activated), Drug: placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- INR below or equal to 1.2
Key exclusion criteria (5 listed)
- The receipt of any investigational drug within 1 month prior to this trial
- Use of anticoagulation therapy-defined as vitamin K antagonists, platelet antagonists, heparin (or low molecular weight heparin), aspirin or NSAIDs (Non-Steroidal Anti-Inflammatory Drug) within 14 days prior to trial
- African-American race
- Weight above 160 kg
- Supplemental Vitamin K use
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 |
|---|---|---|
| warfarinAfter a baseline punch biopsy (B0), warfarin is administered over a period of approximately 7-14 days. Dose is adjusted individually to achieve INR target. Once a stable INR is achieved, a second biopsy (B1) will be performed | Drug | Pre-warfarin treatment (trial part A) |
| eptacog alfa (activated)Also: activated recombinant human factor VIIIf the subject is eligible to continue in trial part B, trial drug will be administered i.v. as a slow bolus injection over 2 to 5 minutes in five different doses followed by two biopsies (B2) and (B3) 15 minutes and 5 hours and 15 minutes, respectively, after trial drug administration | Drug | Post-warfarin treatment (trial part B) |
| placeboIf the subject is eligible to continue in trial part B, trial drug will be administered i.v. as a slow bolus injection over 2 to 5 minutes in five different doses followed by two biopsies (B2) and (B3) 15 minutes and 5 hours and 15 minutes, respectively, after trial drug administration | Drug | Post-warfarin treatment (trial part B) |
Primary outcome
Bleeding duration measured in minutes after biopsies in trial part A
Time frame: From onset of bleeding till the end of the bleeding
Bleeding duration measured in minutes after biopsy B1 in trial part B
Time frame: From onset of bleeding till the end of the bleeding
8 secondary outcomes
Blood volume reported in millilitres after biopsies in trial part A
Time frame: From onset of bleeding till the end of the bleeding
Blood volume reported in millilitres after biopsy B1 in trial part B
Time frame: From onset of bleeding till the end of the bleeding
Adverse events, including thrombotic events
Time frame: From day 0 to days 14-28
Change in coagulation-related parameters after biopsy B1
Time frame: From baseline to 3 hours after B1
Change in coagulation-related parameters after biopsy B2
Time frame: From baseline to 3 hours after B2
Change in coagulation-related parameters after biopsy B3
Time frame: From baseline to 3 hours after B3
Clot dynamics: R in minutes (trial part B)
Time frame: Time to onset of clot formation
Clot dynamics: K in minutes (trial part B)
Time frame: Time to achieve 20mm clot strength
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 25 Nov 2016.
- 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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing warfarin and eptacog alfa (activated) in people with Haemostasis and Healthy, run by Novo Nordisk A/S at 1 site 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 1 inclusion and 5 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 25 Nov 2016. 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 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Bleeding duration measured in minutes after biopsies in trial part A (time frame: From onset of bleeding till the end of the bleeding). 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?
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 25 Nov 2016.