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

Stopped early · Phase 1 · Has a placebo group

Conditions studied: Haemostasis, Healthy

In brief

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®).

Key facts

Study ID

NCT01561950

Run by

Novo Nordisk A/S

People needed

91

Starts

2008-05-01

Expected to finish

2009-01-01

Last updated by the study team

2016-11-23

Who can join

Age: 18 and older, up to 45. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• PT/PTT within normal laboratory range (e.g., PT: 9.4-12.0)
• Platelet count within normal laboratory range

You may not qualify if…

• 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

Where it is running

• Novo Nordisk Investigational Site — Neptune City, New Jersey, United States

Full record on ClinicalTrials.gov

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