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

Primary Purpose

Haemostasis, Healthy

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

warfarin

eptacog alfa (activated)

placebo

About this trial

This is an interventional treatment trial for Haemostasis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleAccepts 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

Sites / Locations

Novo Nordisk Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Pre-warfarin treatment (trial part A)

Post-warfarin treatment (trial part B)

Arm Description

Outcomes

Primary Outcome Measures

Bleeding duration measured in minutes after biopsies in trial part A

Bleeding duration measured in minutes after biopsy B1 in trial part B

Secondary Outcome Measures

Blood volume reported in millilitres after biopsies in trial part A

Blood volume reported in millilitres after biopsy B1 in trial part B

Adverse events, including thrombotic events

Change in coagulation-related parameters after biopsy B1

Change in coagulation-related parameters after biopsy B2

Change in coagulation-related parameters after biopsy B3

Clot dynamics: R in minutes (trial part B)

Clot dynamics: K in minutes (trial part B)

Full Information

NCT ID

NCT01561937

First Posted

March 21, 2012

Last Updated

November 23, 2016

Sponsor

Novo Nordisk A/S

1. Study Identification

Unique Protocol Identification Number

NCT01561937

Brief Title

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

Official Title

Use of Recombinant FVIIa to Mitigate Warfarin Anticoagulation Therapy-Mediated Bleeding in a Single Centre, Randomized, Placebo-controlled, Double-blind Clinical Trial

Study Type

Interventional

2. Study Status

Record Verification Date

November 2016

Overall Recruitment Status

Completed

Study Start Date

January 2007 (undefined)

Primary Completion Date

July 2008 (Actual)

Study Completion Date

July 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novo Nordisk A/S

4. Oversight

Data Monitoring Committee

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Haemostasis, Healthy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

127 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Pre-warfarin treatment (trial part A)

Arm Type

Experimental

Arm Title

Post-warfarin treatment (trial part B)

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

warfarin

Intervention Description

After a baseline punch biopsy (B0), warfarin is administered over a period of approximately 7-14 days. Dose is adjusted individually to achieve INR target. Once a stable INR is achieved, a second biopsy (B1) will be performed

Intervention Type

Drug

Intervention Name(s)

eptacog alfa (activated)

Other Intervention Name(s)

activated recombinant human factor VII

Intervention Description

If the subject is eligible to continue in trial part B, trial drug will be administered i.v. as a slow bolus injection over 2 to 5 minutes in five different doses followed by two biopsies (B2) and (B3) 15 minutes and 5 hours and 15 minutes, respectively, after trial drug administration

Intervention Type

Drug

Intervention Name(s)

placebo

Intervention Description

Primary Outcome Measure Information:

Title

Bleeding duration measured in minutes after biopsies in trial part A

Time Frame

From onset of bleeding till the end of the bleeding

Title

Bleeding duration measured in minutes after biopsy B1 in trial part B

Time Frame

From onset of bleeding till the end of the bleeding

Secondary Outcome Measure Information:

Title

Blood volume reported in millilitres after biopsies in trial part A

Time Frame

From onset of bleeding till the end of the bleeding

Title

Blood volume reported in millilitres after biopsy B1 in trial part B

Time Frame

From onset of bleeding till the end of the bleeding

Title

Adverse events, including thrombotic events

Time Frame

From day 0 to days 14-28

Title

Change in coagulation-related parameters after biopsy B1

Time Frame

From baseline to 3 hours after B1

Title

Change in coagulation-related parameters after biopsy B2

Time Frame

From baseline to 3 hours after B2

Title

Change in coagulation-related parameters after biopsy B3

Time Frame

From baseline to 3 hours after B3

Title

Clot dynamics: R in minutes (trial part B)

Time Frame

Time to onset of clot formation

Title

Clot dynamics: K in minutes (trial part B)

Time Frame

Time to achieve 20mm clot strength

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Global Clinical Registry (GCR, 1452)

Organizational Affiliation

Novo Nordisk A/S

Official's Role

Study Director

Facility Information:

Facility Name

Novo Nordisk Investigational Site

City

Overland Park

State/Province

Kansas

ZIP/Postal Code

66211

Country

United States

12. IPD Sharing Statement

Links:

URL

http://novonordisk-trials.com

Description

Clinical Trials at Novo Nordisk

Learn more about this trial

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

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