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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01561937
Other study ID # F7HAEM-1825
Secondary ID
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


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
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