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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01561937
First Posted: March 23, 2012
Last Update Posted: November 25, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novo Nordisk A/S
  Purpose
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 Intervention Phase
Haemostasis Healthy Drug: warfarin Drug: eptacog alfa (activated) Drug: placebo Phase 1

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Bleeding duration measured in minutes after biopsies in trial part A [ Time Frame: From onset of bleeding till the end of the bleeding ]
  • 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 Outcome Measures:
  • Blood volume reported in millilitres after biopsies in trial part A [ Time Frame: From onset of bleeding till the end of the bleeding ]
  • Blood volume reported in millilitres after biopsy B1 in trial part B [ Time Frame: From onset of bleeding till the end of the bleeding ]
  • Adverse events, including thrombotic events [ Time Frame: From day 0 to days 14-28 ]
  • Change in coagulation-related parameters after biopsy B1 [ Time Frame: From baseline to 3 hours after B1 ]
  • Change in coagulation-related parameters after biopsy B2 [ Time Frame: From baseline to 3 hours after B2 ]
  • Change in coagulation-related parameters after biopsy B3 [ Time Frame: From baseline to 3 hours after B3 ]
  • Clot dynamics: R in minutes (trial part B) [ Time Frame: Time to onset of clot formation ]
  • Clot dynamics: K in minutes (trial part B) [ Time Frame: Time to achieve 20mm clot strength ]

Enrollment: 127
Study Start Date: January 2007
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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

  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01561937


Locations
United States, Kansas
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
  More Information

Additional Information:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01561937     History of Changes
Other Study ID Numbers: F7HAEM-1825
First Submitted: March 21, 2012
First Posted: March 23, 2012
Last Update Posted: November 25, 2016
Last Verified: November 2016

Additional relevant MeSH terms:
Warfarin
Anticoagulants