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

NCT ID: NCT01561950

Last Updated: 2016-11-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

91 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Study Completion Date

2009-01-31

Brief Summary

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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®).

Detailed Description

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Conditions

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Haemostasis Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Factor VII

Group Type EXPERIMENTAL

eptacog alfa (activated)

Intervention Type DRUG

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

Intervention Type DRUG

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

Group Type PLACEBO_COMPARATOR

clopidogrel

Intervention Type DRUG

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

Intervention Type DRUG

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

Interventions

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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

Intervention Type 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).

Intervention Type 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

Intervention Type DRUG

Other Intervention Names

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activated recombinant human factor VII

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Global Clinical Registry (GCR, 1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

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Novo Nordisk Investigational Site

Neptune City, New Jersey, United States

Site Status

Countries

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United States

Related Links

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http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

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F7HAEM-1955

Identifier Type: -

Identifier Source: org_study_id