drugset / Trial / NCT01561937

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

NCT01561937

Phase 1 Completed 127 enrolled Novo Nordisk A/S
RandomizedParallel-groupDouble-blindTreatment

Summary

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).

Timeline

Start
2007-01
Primary completion
2008-07
Completion
2008-07

Drugs

EvaluationDrugModalityDoseRoute
Subject eptacog alfa (activated) Protein / enzyme biologic Intravenous
Background Warfarin Small molecule