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

Sponsor

Novo Nordisk A/S (Industry)

Overall Status

Completed

CT.gov ID

NCT01561937

Collaborator

(none)

127

Enrollment

Location

Arms

Duration (Months)

7.1

Patients Per Site Per Month

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Haemostasis Healthy	Drug: warfarin Drug: eptacog alfa (activated) Drug: placebo	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

127 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

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 Start Date :

Jan 1, 2007

Actual Primary Completion Date :

Jul 1, 2008

Actual Study Completion Date :

Jul 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Pre-warfarin treatment (trial part A)	Drug: warfarin 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
Experimental: Post-warfarin treatment (trial part B)	Drug: eptacog alfa (activated) 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 Other Names: activated recombinant human factor VII Drug: placebo 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

Arm

Intervention/Treatment

Experimental: Pre-warfarin treatment (trial part A)

Drug: warfarin

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

Experimental: Post-warfarin treatment (trial part B)

Drug: eptacog alfa (activated)

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

Other Names:

activated recombinant human factor VII

Drug: placebo

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novo Nordisk Investigational Site	Overland Park	Kansas	United States	66211

Sponsors and Collaborators

Novo Nordisk A/S

Investigators

Study Director: Global Clinical Registry (GCR, 1452), Novo Nordisk A/S

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Clinical Trials at Novo Nordisk

Publications

None provided.

Responsible Party:

Novo Nordisk A/S

ClinicalTrials.gov Identifier:

NCT01561937

Other Study ID Numbers:

F7HAEM-1825

First Posted:

Mar 23, 2012

Last Update Posted:

Nov 25, 2016

Last Verified:

Nov 1, 2016

Additional relevant MeSH terms:

Hemorrhage

Warfarin

Study Results

No Results Posted as of Nov 25, 2016