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Safety of rFXIII in Patients Following First Time Myocardial Revascularization Requiring Cardiopulmonary Bypass

NCT ID: NCT02239146

Last Updated: 2017-01-11

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

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-10-31

Study Completion Date

2008-01-31

Brief Summary

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This trial is conducted in Europe and the United States of America (USA). The aim of this trial is to evaluate the safety of escalating single doses of rFXIII (recombinant factor XIII, catridecacog) administered following first time myocardial revascularization requiring cardiopulmonary bypass (CPB).

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Detailed Description

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Conditions

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Acquired Bleeding Disorder Cardiac Surgery Requiring Cardiopulmonary Bypass

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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rFXIII

Group Type EXPERIMENTAL

catridecacog

Intervention Type DRUG

Single doses of rFXIII administered intravenously (i.v.) to eight subjects in each of the four dose groups (11.9, 25, 35 and 50 IU/kg).

Placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Single doses of placebo administered intravenously (i.v.) to two subjects in each of the four dose groups (11.9, 25, 35 and 50 IU/kg).

Interventions

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catridecacog

Single doses of rFXIII administered intravenously (i.v.) to eight subjects in each of the four dose groups (11.9, 25, 35 and 50 IU/kg).

Intervention Type DRUG

placebo

Single doses of placebo administered intravenously (i.v.) to two subjects in each of the four dose groups (11.9, 25, 35 and 50 IU/kg).

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Subject is undergoing his/her first myocardial revascularization

Exclusion Criteria

* Previous participation (randomisation and dosing) in this trial
* Subject has a history of cerebrovascular event (including thrombotic or haemorrhagic stroke or transient ischaemic attack (TIA)) and/or extra-myocardial thromboembolic events, e.g., deep vein thrombosis (DVT) or pulmonary embolus (PE)
* Subject required a pre-operative (within 30 days) transfusion of any blood and/or blood product
* Subject has a current atrial fibrillation or history of atrial fibrillation
Minimum Eligible Age

35 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

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

Tucson, Arizona, United States

Site Status

Novo Nordisk Investigational Site

San Francisco, California, United States

Site Status

Novo Nordisk Investigational Site

Denver, Colorado, United States

Site Status

Novo Nordisk Investigational Site

Indianapolis, Indiana, United States

Site Status

Novo Nordisk Investigational Site

Camden, New Jersey, United States

Site Status

Novo Nordisk Investigational Site

New York, New York, United States

Site Status

Novo Nordisk Investigational Site

The Bronx, New York, United States

Site Status

Novo Nordisk Investigational Site

The Bronx, New York, United States

Site Status

Novo Nordisk Investigational Site

Cleveland, Ohio, United States

Site Status

Novo Nordisk Investigational Site

Portland, Oregon, United States

Site Status

Novo Nordisk Investigational Site

Portland, Oregon, United States

Site Status

Novo Nordisk Investigational Site

Allentown, Pennsylvania, United States

Site Status

Novo Nordisk Investigational Site

Philadelphia, Pennsylvania, United States

Site Status

Novo Nordisk Investigational Site

Houston, Texas, United States

Site Status

Novo Nordisk Investigational Site

Richmond, Virginia, United States

Site Status

Novo Nordisk Investigational Site

Toronto, , Canada

Site Status

Novo Nordisk Investigational Site

København Ø, , Denmark

Site Status

Novo Nordisk Investigational Site

Hamburg, , Germany

Site Status

Novo Nordisk Investigational Site

Lahr, , Germany

Site Status

Novo Nordisk Investigational Site

Mainz, , Germany

Site Status

Novo Nordisk Investigational Site

Cambridge, , United Kingdom

Site Status

Novo Nordisk Investigational Site

London, , United Kingdom

Site Status

Novo Nordisk Investigational Site

Middlesbrough, , United Kingdom

Site Status

Novo Nordisk Investigational Site

Southampton, , United Kingdom

Site Status

Countries

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United States Canada Denmark Germany United Kingdom

References

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Levy JH, Gill R, Nussmeier NA, Olsen PS, Andersen HF, Booth FV, Jespersen CM. Repletion of factor XIII following cardiopulmonary bypass using a recombinant A-subunit homodimer. A preliminary report. Thromb Haemost. 2009 Oct;102(4):765-71. doi: 10.1160/TH08-12-0826.

Reference Type RESULT
PMID: 19806264 (View on PubMed)

Related Links

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http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

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2005-000729-40

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

F13CARD-1660

Identifier Type: -

Identifier Source: org_study_id

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