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

NCT01561950 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 91

Last updated 2016-11-23

No results posted yet for this study

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®).

Conditions

  • Haemostasis
  • Healthy

Interventions

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

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

Sponsors & Collaborators

Principal Investigators

  • Global Clinical Registry (GCR, 1452) · Novo Nordisk A/S

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-05-31
Primary Completion
2009-01-31
Completion
2009-01-31

Countries

  • United States

Study Locations

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Entities

Drugs
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01561950 on ClinicalTrials.gov