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Completed

NCT Number: NCT01561937

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

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).

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Key information

Conditions

Haemostasis Healthy

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Novo Nordisk Investigational Site

Overland Park, Kansas, 66211, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Warfarin

Drug

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)

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

Other names: activated recombinant human factor VII

Placebo

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

Primary outcomes

  1. Bleeding duration measured in minutes after biopsies in trial part A

    Time frame: From onset of bleeding till the end of the bleeding

  2. 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 outcomes

  1. Blood volume reported in millilitres after biopsies in trial part A

    Time frame: From onset of bleeding till the end of the bleeding

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

    Time frame: From onset of bleeding till the end of the bleeding

  3. Adverse events, including thrombotic events

    Time frame: From day 0 to days 14-28

  4. Change in coagulation-related parameters after biopsy B1

    Time frame: From baseline to 3 hours after B1

  5. Change in coagulation-related parameters after biopsy B2

    Time frame: From baseline to 3 hours after B2

  6. Change in coagulation-related parameters after biopsy B3

    Time frame: From baseline to 3 hours after B3

  7. Clot dynamics: R in minutes (trial part B)

    Time frame: Time to onset of clot formation

  8. Clot dynamics: K in minutes (trial part B)

    Time frame: Time to achieve 20mm clot strength

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Mar 23, 2012
Registry last updated
Nov 25, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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