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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01561950
• Other study ID #: F7HAEM-1955
• Status: Terminated
• Phase: Phase 1
• First received: March 21, 2012
• Last updated: November 22, 2016
• Start date: May 2008
• Est. completion date: January 2009

Study information

• Verified date: November 2016
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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®).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 91
• Est. completion date: January 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Haemostasis
• Healthy

Intervention

Drug:
• eptacog alfa (activated)
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
• 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
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

Locations

Country	Name	City	State
United States	Novo Nordisk Investigational Site	Neptune	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bleeding duration measured in minutes		From onset of bleeding till the end of the bleeding	No
Secondary	Blood volume reported in millilitres		From onset of bleeding till the end of the bleeding	No
Secondary	Clot dynamics on the TEG (thromboelastograph hemostasis analyzer): R in minutes		Time to onset of clot formation	No
Secondary	Clot dynamics on the TEG (thromboelastograph hemostasis analyzer): K in minutes		Time to achieve 20 mm clot strength	No
Secondary	Adverse events, including thrombotic events		From screening to day 11-18	No
Secondary	Change in coagulation-related parameters after pre-biopsy		From baseline to 15 minutes after pre-biopsy	No
Secondary	Change in coagulation-related parameters after biopsy B2		From baseline to 3 hours after B2	No
Secondary	Change in coagulation-related parameters after biopsy B3		From baseline to 1 hour after B3	No

External Links

•   Clinical Trials at Novo Nordisk