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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01561937
• Other study ID #: F7HAEM-1825
• Status: Completed
• Phase: Phase 1
• First received: March 21, 2012
• Last updated: November 23, 2016
• Start date: January 2007
• Est. completion date: July 2008

Study information

• Verified date: November 2016
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 127
• Est. completion date: July 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Haemostasis
• Healthy

Intervention

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
• 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
• 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

Locations

Country	Name	City	State
United States	Novo Nordisk Investigational Site	Overland Park	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bleeding duration measured in minutes after biopsies in trial part A		From onset of bleeding till the end of the bleeding	No
Primary	Bleeding duration measured in minutes after biopsy B1 in trial part B		From onset of bleeding till the end of the bleeding	No
Secondary	Blood volume reported in millilitres after biopsies in trial part A		From onset of bleeding till the end of the bleeding	No
Secondary	Blood volume reported in millilitres after biopsy B1 in trial part B		From onset of bleeding till the end of the bleeding	No
Secondary	Adverse events, including thrombotic events		From day 0 to days 14-28	No
Secondary	Change in coagulation-related parameters after biopsy B1		From baseline to 3 hours after B1	No
Secondary	Change in coagulation-related parameters after biopsy B2		From baseline to 3 hours after B2	No
Secondary	Change in coagulation-related parameters after biopsy B3		From baseline to 3 hours after B3	No
Secondary	Clot dynamics: R in minutes (trial part B)		Time to onset of clot formation	No
Secondary	Clot dynamics: K in minutes (trial part B)		Time to achieve 20mm clot strength	No

External Links

•   Clinical Trials at Novo Nordisk