Efficacy of Activated Recombinant Human Factor VII in Healthy Volunteers Treated for Punch Biopsy Mediated Bleeding

Study Overview
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Brief Summary
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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®).

Official Title
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Use of Recombinant FVIIa to Mitigate Clopidogrel Anti-platelet Therapy-Mediated Bleeding in a Single Centre, Randomized, Placebo-controlled, Double-blind Clinical Trial

Conditions
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Haemostasis, Healthy

Intervention / Treatment
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* Drug: eptacog alfa (activated)
* Drug: clopidogrel
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: PT/PTT within normal laboratory range (e.g., PT: 9.4-12.0) Platelet count within normal laboratory range Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Factor VII<br> | Drug: eptacog alfa (activated)<br>* 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<br>* Other names: activated recombinant human factor VII;Drug: clopidogrel<br>* 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).<br>|
| Placebo Comparator: Placebo<br> | Drug: clopidogrel<br>* 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).<br>Drug: placebo<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bleeding duration measured in minutes |  | From onset of bleeding till the end of the bleeding | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood volume reported in millilitres |  | From onset of bleeding till the end of the bleeding | 
| Clot dynamics on the TEG (thromboelastograph hemostasis analyzer): R in minutes |  | Time to onset of clot formation | 
| Clot dynamics on the TEG (thromboelastograph hemostasis analyzer): K in minutes |  | Time to achieve 20 mm clot strength | 
| Adverse events, including thrombotic events |  | From screening to day 11-18 | 
| Change in coagulation-related parameters after pre-biopsy |  | From baseline to 15 minutes after pre-biopsy | 
| Change in coagulation-related parameters after biopsy B2 |  | From baseline to 3 hours after B2 | 
| Change in coagulation-related parameters after biopsy B3 |  | From baseline to 1 hour after B3 |