Back to resultsEfficacy of Activated Recombinant Human Factor VII in Healthy Volunteers Treated for Punch Biopsy Mediated Bleeding
Primary Purpose
Haemostasis, Healthy
Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
eptacog alfa (activated)
clopidogrel
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Haemostasis
Eligibility 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
Sites / Locations
- Novo Nordisk Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Factor VII
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Bleeding duration measured in minutes
Secondary Outcome Measures
Blood volume reported in millilitres
Clot dynamics on the TEG (thromboelastograph hemostasis analyzer): R in minutes
Clot dynamics on the TEG (thromboelastograph hemostasis analyzer): K in minutes
Adverse events, including thrombotic events
Change in coagulation-related parameters after pre-biopsy
Change in coagulation-related parameters after biopsy B2
Change in coagulation-related parameters after biopsy B3
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01561950
Brief Title
Efficacy of Activated Recombinant Human Factor VII in Healthy Volunteers Treated for Punch Biopsy Mediated Bleeding
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Terminated
Study Start Date
May 2008 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
January 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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®).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Haemostasis, Healthy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
91 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Factor VII
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
eptacog alfa (activated)
Other Intervention Name(s)
activated recombinant human factor VII
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
clopidogrel
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
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
Primary Outcome Measure Information:
Title
Bleeding duration measured in minutes
Time Frame
From onset of bleeding till the end of the bleeding
Secondary Outcome Measure Information:
Title
Blood volume reported in millilitres
Time Frame
From onset of bleeding till the end of the bleeding
Title
Clot dynamics on the TEG (thromboelastograph hemostasis analyzer): R in minutes
Time Frame
Time to onset of clot formation
Title
Clot dynamics on the TEG (thromboelastograph hemostasis analyzer): K in minutes
Time Frame
Time to achieve 20 mm clot strength
Title
Adverse events, including thrombotic events
Time Frame
From screening to day 11-18
Title
Change in coagulation-related parameters after pre-biopsy
Time Frame
From baseline to 15 minutes after pre-biopsy
Title
Change in coagulation-related parameters after biopsy B2
Time Frame
From baseline to 3 hours after B2
Title
Change in coagulation-related parameters after biopsy B3
Time Frame
From baseline to 1 hour after B3
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Registry (GCR, 1452)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Neptune
State/Province
New Jersey
ZIP/Postal Code
07753
Country
United States
12. IPD Sharing Statement
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk
Learn more about this trial
Efficacy of Activated Recombinant Human Factor VII in Healthy Volunteers Treated for Punch Biopsy Mediated Bleeding
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