Efficacy of Activated Recombinant Human Factor VII in Healthy Volunteers Treated for Punch Biopsy Mediated Bleeding
| Status: | Terminated |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 45 |
| Updated: | 11/24/2016 |
| Start Date: | May 2008 |
| End Date: | January 2009 |
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®).
to evaluate the effectiveness of activated recombinant human factor VII to mitigate
experimentally-induced bleeding in healthy volunteers treated with clopidogrel (Plavix®).
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
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