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

Phase 1

Completed

• Conditions: Haemostasis; Healthy
• Interventions: Drug: eptacog alfa (activated); Drug: warfarin; Drug: placebo

• Registration Number: NCT01561937
• Lead Sponsor: Novo Nordisk A/S

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2007-01
• Primary Completion: 2008-07
• Study Completion: 2008-07
• Study First Submitted: 2012-03-21
• Study First Submitted QC: 2012-03-22
• Study First Posted: 2012-03-23
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-23
• Last Update Posted: 2016-11-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 127

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Post-warfarin treatment (trial part B)	eptacog alfa (activated)	-
Post-warfarin treatment (trial part B)	placebo	-
Pre-warfarin treatment (trial part A)	warfarin	-

Primary Outcome Measures

Name	Time	Method
Bleeding duration measured in minutes after biopsy B1 in trial part B	From onset of bleeding till the end of the bleeding
Bleeding duration measured in minutes after biopsies in trial part A	From onset of bleeding till the end of the bleeding

Secondary Outcome Measures

Name	Time	Method
Adverse events, including thrombotic events	From day 0 to days 14-28
Blood volume reported in millilitres after biopsies in trial part A	From onset of bleeding till the end of the bleeding
Change in coagulation-related parameters after biopsy B1	From baseline to 3 hours after B1
Change in coagulation-related parameters after biopsy B2	From baseline to 3 hours after B2
Blood volume reported in millilitres after biopsy B1 in trial part B	From onset of bleeding till the end of the bleeding
Clot dynamics: K in minutes (trial part B)	Time to achieve 20mm clot strength
Clot dynamics: R in minutes (trial part B)	Time to onset of clot formation
Change in coagulation-related parameters after biopsy B3	From baseline to 3 hours after B3

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇺🇸 Overland Park, Kansas, United States