Efficacy of Activated Recombinant Human Factor VII in Healthy Volunteers Treated for Punch Biopsy Mediated Bleeding

This study has been terminated.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01561950
First received: March 21, 2012
Last updated: March 22, 2012
Last verified: March 2012
  Purpose

This trial is conducted in the United States of the America (USA). The aim of this trial is to evaluate the effectiveness of activated recombinant human factor VII to mitigate experimentally-induced bleeding in healthy volunteers treated with clopidogrel (Plavix®).


Condition Intervention Phase
Haemostasis
Healthy
Drug: activated recombinant human factor VII
Drug: clopidogrel
Drug: placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Use of Recombinant FVIIa to Mitigate Clopidogrel Anti-platelet 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 [ 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 [ Time Frame: From onset of bleeding till the end of the bleeding ] [ Designated as safety issue: No ]
  • Clot dynamics on the TEG (thromboelastograph hemostasis analyzer): R in minutes [ Time Frame: Time to onset of clot formation ] [ Designated as safety issue: No ]
  • Clot dynamics on the TEG (thromboelastograph hemostasis analyzer): K in minutes [ Time Frame: Time to achieve 20 mm clot strength ] [ Designated as safety issue: No ]
  • Adverse events, including thrombotic events [ Time Frame: From screening to day 11-18 ] [ Designated as safety issue: No ]
  • Change in coagulation-related parameters after pre-biopsy [ Time Frame: From baseline to 15 minutes after pre-biopsy ] [ 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 1 hour after B3 ] [ Designated as safety issue: No ]

Enrollment: 91
Study Start Date: May 2008
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Factor VII Drug: activated recombinant human factor VII
If subject is eligible to continue after clopidogrel treatment, three different doses of trial drug is administered i.v. as a slow bolus injection over two to three minutes followed by post-trial biopsies
Drug: clopidogrel
Following a baseline biopsy (B0) subjects will receive oral treatment with an initial 300 mg loading dose followed by daily 75 mg doses for at least 3 additional days. If the target platelet inhibition (PI) is achieved, the subject will undergo punch biopsy 1 (B1).
Placebo Comparator: Placebo Drug: clopidogrel
Following a baseline biopsy (B0) subjects will receive oral treatment with an initial 300 mg loading dose followed by daily 75 mg doses for at least 3 additional days. If the target platelet inhibition (PI) is achieved, the subject will undergo punch biopsy 1 (B1).
Drug: placebo
If subject is eligible to continue after clopidogrel treatment, three different doses of trial drug is administered i.v. as a slow bolus injection over two to three minutes followed by post-trial biopsies

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • PT/PTT within normal laboratory range (e.g., PT: 9.4-12.0)
  • Platelet count within normal laboratory range

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 30 days prior to trial
  • African-American race
  • Weight above or equal to 160 kg
  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: NCT01561950

Locations
United States, New Jersey
Novo Nordisk Clinical Trial Call Center
Neptune, New Jersey, United States, 07753
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: NCT01561950     History of Changes
Other Study ID Numbers: F7HAEM-1955
Study First Received: March 21, 2012
Last Updated: March 22, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hemorrhage
Pathologic Processes
Clopidogrel
Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 20, 2014