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

January 10, 2017 updated by: Novo Nordisk A/S

A Multi-Centre, Randomised, Double-Blind, Placebo Controlled, Dose Escalation Trial on Safety and Pharmacokinetics of Recombinant Factor XIII (rFXIII) in Patients Following First Time Myocardial Revascularization Requiring Cardiopulmonary Bypass

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

43

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Toronto, Canada, M5G-2C4
        • Novo Nordisk Investigational Site
  • Denmark
      • København ø, Denmark, 2100
        • Novo Nordisk Investigational Site
  • Germany
      • Hamburg, Germany, 20246
        • Novo Nordisk Investigational Site
      • Lahr, Germany, 77933
        • Novo Nordisk Investigational Site
      • Mainz, Germany, 55131
        • Novo Nordisk Investigational Site
  • United Kingdom
      • Cambridge, United Kingdom, CB3 8RE
        • Novo Nordisk Investigational Site
      • London, United Kingdom, W1G 8PH
        • Novo Nordisk Investigational Site
      • Middlesborough, United Kingdom, TS4 3BW
        • Novo Nordisk Investigational Site
      • Southampton, United Kingdom, SO16 6YD
        • Novo Nordisk Investigational Site
  • United States
    • Arizona
      • Tucson, Arizona, United States, 85714
        • Novo Nordisk Investigational Site
    • California
      • San Francisco, California, United States, 94143
        • Novo Nordisk Investigational Site
    • Colorado
      • Denver, Colorado, United States, 80262
        • Novo Nordisk Investigational Site
    • Indiana
      • Indianapolis, Indiana, United States, 46290
        • Novo Nordisk Investigational Site
    • New Jersey
      • Camden, New Jersey, United States, 08103
        • Novo Nordisk Investigational Site
    • New York
      • Bronx, New York, United States, 10467
        • Novo Nordisk Investigational Site
      • Bronx, New York, United States, 10461
        • Novo Nordisk Investigational Site
      • New York, New York, United States, 10032
        • Novo Nordisk Investigational Site
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Novo Nordisk Investigational Site
    • Oregon
      • Portland, Oregon, United States, 97207
        • Novo Nordisk Investigational Site
      • Portland, Oregon, United States, 97239-3098
        • Novo Nordisk Investigational Site
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18103
        • Novo Nordisk Investigational Site
      • Philadelphia, Pennsylvania, United States, 19107-5092
        • Novo Nordisk Investigational Site
    • Texas
      • Houston, Texas, United States, 77030
        • Novo Nordisk Investigational Site
    • Virginia
      • Richmond, Virginia, United States, 23298
        • Novo Nordisk Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
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).
Experimental: rFXIII
Drug: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence and severity of adverse events
Time Frame: From dosing up to 5-7 weeks ± 3 days after trial product administration
From dosing up to 5-7 weeks ± 3 days after trial product administration

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence and magnitude of laboratory abnormalities following administration of rFXIII
Time Frame: From dosing up to 5-7 weeks ± 3 days after trial product administration
From dosing up to 5-7 weeks ± 3 days after trial product administration
Incidence of antibodies to FXIII-A subunit
Time Frame: From dosing up to 5-7 weeks ± 3 days after trial product administration
From dosing up to 5-7 weeks ± 3 days after trial product administration
Incidence of anti-yeast antibodies
Time Frame: From dosing up to 5-7 weeks ± 3 days after trial product administration
From dosing up to 5-7 weeks ± 3 days after trial product administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2005

Primary Completion (Actual)

January 1, 2008

Study Completion (Actual)

January 1, 2008

Study Registration Dates

First Submitted

September 10, 2014

First Submitted That Met QC Criteria

September 10, 2014

First Posted (Estimate)

September 12, 2014

Study Record Updates

Last Update Posted (Estimate)

January 11, 2017

Last Update Submitted That Met QC Criteria

January 10, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • F13CARD-1660
  • 2005-000729-40 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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