Use of Activated Recombinant Human Factor VII to Reduce Bleeding Caused by Warfarin Treatment

Completed · Phase 1 · Has a placebo group

Conditions studied: Haemostasis, Healthy

In brief

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).

Key facts

Study ID

NCT01561937

Run by

Novo Nordisk A/S

People needed

127

Starts

2007-01-01

Expected to finish

2008-07-01

Last updated by the study team

2016-11-25

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• INR below or equal to 1.2

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 14 days prior to trial
• African-American race
• Weight above 160 kg
• Supplemental Vitamin K use

Where it is running

• Novo Nordisk Investigational Site — Overland Park, Kansas, United States

Full record on ClinicalTrials.gov

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