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

Use of Recombinant FVIIa to Mitigate Clopidogrel Anti-platelet Therapy-Mediated Bleeding in a Single Centre, Randomized, Placebo-controlled, Double-blind Clinical Trial

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®).

Study Overview

• Status: Terminated
• Conditions: Healthy; Haemostasis
• Intervention / Treatment: Drug: eptacog alfa (activated); Drug: clopidogrel; Drug: placebo

• Study Type: Interventional
• Enrollment (Actual): 91
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Neptune, New Jersey, United States, 07753
      • Novo Nordisk Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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
Experimental: Factor VII	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; Other Names: activated recombinant human factor VII; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Bleeding duration measured in minutes	From onset of bleeding till the end of the bleeding

Secondary Outcome Measures

Outcome Measure	Time Frame
Blood volume reported in millilitres	From onset of bleeding till the end of the bleeding
Change in coagulation-related parameters after biopsy B2	From baseline to 3 hours after B2
Clot dynamics on the TEG (thromboelastograph hemostasis analyzer): R in minutes	Time to onset of clot formation
Clot dynamics on the TEG (thromboelastograph hemostasis analyzer): K in minutes	Time to achieve 20 mm clot strength
Adverse events, including thrombotic events	From screening to day 11-18
Change in coagulation-related parameters after pre-biopsy	From baseline to 15 minutes after pre-biopsy
Change in coagulation-related parameters after biopsy B3	From baseline to 1 hour after B3

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S

Publications and helpful links

Helpful Links

• Clinical Trials at Novo Nordisk

Study record dates

Study Major Dates

• Study Start: May 1, 2008
• Primary Completion (Actual): January 1, 2009
• Study Completion (Actual): January 1, 2009

Study Registration Dates

• First Submitted: March 21, 2012
• First Submitted That Met QC Criteria: March 22, 2012
• First Posted (Estimate): March 23, 2012

Study Record Updates

• Last Update Posted (Estimate): November 23, 2016
• Last Update Submitted That Met QC Criteria: November 22, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Platelet Aggregation Inhibitors; Purinergic P2Y Receptor Antagonists; Purinergic P2 Receptor Antagonists; Purinergic Antagonists; Purinergic Agents; Clopidogrel
• Other Study ID Numbers: F7HAEM-1955