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

Novo Nordisk

Status and phase: Completed; Phase 1

Conditions: Healthy; Haemostasis

Treatments: Drug: eptacog alfa (activated); Drug: warfarin; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01561937

F7HAEM-1825

Details and patient eligibility

About

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).

Enrollment: 127 patients

Sex: Male

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• INR below or equal to 1.2

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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127 participants in 2 patient groups

Pre-warfarin treatment (trial part A)

Experimental group

Treatment:

Drug: warfarin

Post-warfarin treatment (trial part B)

Experimental group

Treatment:

Drug: placebo

Drug: eptacog alfa (activated)