Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01561937
First received: March 21, 2012
Last updated: March 22, 2012
Last verified: March 2012
  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: activated recombinant human factor VII
Drug: placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]
  • Bleeding duration measured in minutes after biopsy B1 in trial part B [ Time Frame: From onset of bleeding till the end of the bleeding ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
  • Blood volume reported in millilitres after biopsy B1 in trial part B [ Time Frame: From onset of bleeding till the end of the bleeding ] [ Designated as safety issue: No ]
  • Adverse events, including thrombotic events [ Time Frame: From day 0 to days 14-28 ] [ Designated as safety issue: No ]
  • Change in coagulation-related parameters after biopsy B1 [ Time Frame: From baseline to 3 hours after B1 ] [ Designated as safety issue: No ]
  • Change in coagulation-related parameters after biopsy B2 [ Time Frame: From baseline to 3 hours after B2 ] [ Designated as safety issue: No ]
  • Change in coagulation-related parameters after biopsy B3 [ Time Frame: From baseline to 3 hours after B3 ] [ Designated as safety issue: No ]
  • Clot dynamics: R in minutes (trial part B) [ Time Frame: Time to onset of clot formation ] [ Designated as safety issue: No ]
  • Clot dynamics: K in minutes (trial part B) [ Time Frame: Time to achieve 20mm clot strength ] [ Designated as safety issue: No ]

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: activated recombinant human factor VII
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
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

Ages Eligible for Study:   18 Years to 45 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01561937

Locations
United States, Kansas
Novo Nordisk Clinical Trial Call Center
Overland Park, Kansas, United States, 66211
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Brett E. Skolnick, Ph.D. Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01561937     History of Changes
Other Study ID Numbers: F7HAEM-1825
Study First Received: March 21, 2012
Last Updated: March 22, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Warfarin
Anticoagulants
Hematologic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014