NCT01561937

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
127

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jan 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

March 21, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 23, 2012

Completed
Last Updated

November 25, 2016

Status Verified

November 1, 2016

Enrollment Period

1.5 years

First QC Date

March 21, 2012

Last Update Submit

November 23, 2016

Conditions

HaemostasisHealthy

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (8)

  • 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

  • +3 more secondary outcomes

Study Arms (2)

Pre-warfarin treatment (trial part A)

EXPERIMENTAL
Drug: warfarin

Post-warfarin treatment (trial part B)

EXPERIMENTAL
Drug: eptacog alfa (activated)Drug: placebo

Interventions

warfarinDRUG

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

Pre-warfarin treatment (trial part A)
eptacog alfa (activated)DRUG

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

Also known as: activated recombinant human factor VII
Post-warfarin treatment (trial part B)
placeboDRUG

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

Post-warfarin treatment (trial part B)

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • INR below or equal to 1.2

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novo Nordisk Investigational Site

Overland Park, Kansas, 66211, United States

Location

Related Links

MeSH Terms

Interventions

WarfarinFactor VII

Intervention Hierarchy (Ancestors)

4-HydroxycoumarinsCoumarinsBenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingEnzyme PrecursorsEnzymes and CoenzymesBlood Coagulation FactorsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsProtein PrecursorsBiological Factors

Study Officials

  • Global Clinical Registry (GCR, 1452)

    Novo Nordisk A/S

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 21, 2012

First Posted

March 23, 2012

Study Start

January 1, 2007

Primary Completion

July 1, 2008

Study Completion

July 1, 2008

Last Updated

November 25, 2016

Record last verified: 2016-11

Locations

US(1)