HaemostasisPhase 1NCT01561950
Efficacy of Activated Recombinant Human Factor VII in Healthy Volunteers Treated for Punch Biopsy Mediated Bleeding
A Phase 1 study testing eptacog alfa (activated) and clopidogrel 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 the America (USA). The aim of this trial is to evaluate the effectiveness of activated recombinant human factor VII to mitigate experimentally-induced bleeding in healthy volunteers treated with clopidogrel (Plavix®). Read more about this study
- Who is it for?
- Ages 18 to 45 years, men only
- Conditions the study is for
- Haemostasis, Healthy
- What is being tested?
- eptacog alfa (activated) and clopidogrel
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 91 participants
- Where
- 1 siteUnited States
- Study dates
- May 2008to Jan 2009
- 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 to 45 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- PT/PTT within normal laboratory range (e.g., PT: 9.4-12.0)
- Platelet count within normal laboratory range
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 30 days prior to trial
- African-American race
- Weight above or equal to 160 kg
Trial locations and contacts
1 site in 1 country.
United States1 site
Novo Nordisk Investigational Site
Neptune City, New Jersey, 07753
About this study
Official title: Use of Recombinant FVIIa to Mitigate Clopidogrel Anti-platelet Therapy-Mediated Bleeding in a Single Centre, Randomized, Placebo-controlled, Double-blind Clinical Trial
This trial is conducted in the United States of the America (USA). The aim of this trial is to evaluate the effectiveness of activated recombinant human factor VII to mitigate experimentally-induced bleeding in healthy volunteers treated with clopidogrel (Plavix®).
- Conditions
- Haemostasis, Healthy
- Being tested
- eptacog alfa (activated), clopidogrel, placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eptacog alfa (activated)Drug
Also called activated recombinant human factor VII
If subject is eligible to continue after clopidogrel treatment, three different doses of trial drug is administered i.v. as a slow bolus injection over two to three minutes followed by post-trial biopsies
clopidogrelDrug
Following a baseline biopsy (B0) subjects will receive oral treatment with an initial 300 mg loading dose followed by daily 75 mg doses for at least 3 additional days. If the target platelet inhibition (PI) is achieved, the subject will undergo punch biopsy 1 (B1).
placeboDrug
If subject is eligible to continue after clopidogrel treatment, three different doses of trial drug is administered i.v. as a slow bolus injection over two to three minutes followed by post-trial biopsies
| Study group | Role | What they receive |
|---|---|---|
| Factor VII | Experimental | Not described Receives: Drug: eptacog alfa (activated); Drug: clopidogrel |
| Placebo | Placebo comparator | Not described Receives: Drug: clopidogrel; Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bleeding duration measured in minutes
Measured: From onset of bleeding till the end of the bleeding
Secondary outcomes (7)
Blood volume reported in millilitres
Measured: From onset of bleeding till the end of the bleeding
Clot dynamics on the TEG (thromboelastograph hemostasis analyzer): R in minutes
Measured: Time to onset of clot formation
Clot dynamics on the TEG (thromboelastograph hemostasis analyzer): K in minutes
Measured: Time to achieve 20 mm clot strength
Adverse events, including thrombotic events
Measured: From screening to day 11-18
Change in coagulation-related parameters after pre-biopsy
Measured: From baseline to 15 minutes after pre-biopsy
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 1 hour after B3
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 startMay 2008
- Primary completionJan 2009
- Study completionJan 2009
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
- 91 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
- NCT01561950
- Sponsor's protocol ID
- F7HAEM-1955
- Status last verified
- Nov 2016
- First submitted
- 21 Mar 2012
- Last updated
- 23 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Recombinant FVIIa to Mitigate Clopidogrel Anti-platelet Therapy-Mediated Bleeding in a Single Centre, Randomized, Placebo-controlled, Double-blind Clinical Trial
- ClinicalTrials.gov ID
- NCT01561950
- Acronym / sponsor ID
- F7HAEM-1955
- Conditions
- Haemostasis, Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- May 2008
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (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 the America (USA). The aim of this trial is to evaluate the effectiveness of activated recombinant human factor VII to mitigate experimentally-induced bleeding in healthy volunteers treated with clopidogrel (Plavix®).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Factor VII | Experimental | Drug: eptacog alfa (activated), Drug: clopidogrel |
| Placebo | Placebo comparator | Drug: clopidogrel, Drug: placebo |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- PT/PTT within normal laboratory range (e.g., PT: 9.4-12.0)
- Platelet count within normal laboratory range
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 30 days prior to trial
- African-American race
- Weight above or equal to 160 kg
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 |
|---|---|---|
| eptacog alfa (activated)Also: activated recombinant human factor VIIIf subject is eligible to continue after clopidogrel treatment, three different doses of trial drug is administered i.v. as a slow bolus injection over two to three minutes followed by post-trial biopsies | Drug | Factor VII |
| clopidogrelFollowing a baseline biopsy (B0) subjects will receive oral treatment with an initial 300 mg loading dose followed by daily 75 mg doses for at least 3 additional days. If the target platelet inhibition (PI) is achieved, the subject will undergo punch biopsy 1 (B1). | Drug | Factor VII, Placebo |
| placeboIf subject is eligible to continue after clopidogrel treatment, three different doses of trial drug is administered i.v. as a slow bolus injection over two to three minutes followed by post-trial biopsies | Drug | Placebo |
Primary outcome
Bleeding duration measured in minutes
Time frame: From onset of bleeding till the end of the bleeding
7 secondary outcomes
Blood volume reported in millilitres
Time frame: From onset of bleeding till the end of the bleeding
Clot dynamics on the TEG (thromboelastograph hemostasis analyzer): R in minutes
Time frame: Time to onset of clot formation
Clot dynamics on the TEG (thromboelastograph hemostasis analyzer): K in minutes
Time frame: Time to achieve 20 mm clot strength
Adverse events, including thrombotic events
Time frame: From screening to day 11-18
Change in coagulation-related parameters after pre-biopsy
Time frame: From baseline to 15 minutes after pre-biopsy
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 1 hour after B3
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 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 eptacog alfa (activated) and clopidogrel 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 2 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: stopped early, as of the sponsor's last update on 23 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. 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 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 was stopped early. Results are not available in the source record.
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 (time frame: From onset of bleeding till the end of the bleeding). 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 23 Nov 2016.