Multi-national Study Investigating the Effect and Safety of rFXIII on Transfusion Needs in Patients Undergoing Heart Surgery

January 23, 2017 updated by: Novo Nordisk A/S

A Multi-Centre, Randomised, Double-Blind, Placebo Controlled Trial on Efficacy and Safety of FXIII Replenishment With Two Different Doses of Recombinant Factor XIII Following Cardiopulmonary Bypass Surgery

This trial is conducted in Canada, Asia, Europe and USA. The aim of this clinical trial is to investigate the effect and safety of rFXIII on transfusion needs in patients undergoing heart surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

479

Phase

  • Phase 2

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
      • Montreal, Canada, H1T 1C8
        • Novo Nordisk Investigational Site
      • Ottawa, Canada, K1Y 4W7
        • Novo Nordisk Investigational Site
      • Quebec, Canada, G1V 4G5
        • Novo Nordisk Investigational Site
      • Toronto, Canada, M5G-2C4
        • Novo Nordisk Investigational Site
    • Ontario
      • Toronto, Ontario, Canada, M5B 1W8
        • Novo Nordisk Investigational Site
  • Denmark
      • København ø, Denmark, 2100
        • Novo Nordisk Investigational Site
  • Germany
      • Berlin, Germany, 13353
        • Novo Nordisk Investigational Site
      • Frankfurt am Main, Germany, 60590
        • Novo Nordisk Investigational Site
      • Ludwigshafen, Germany, 67063
        • Novo Nordisk Investigational Site
      • München, Germany, 80636
        • Novo Nordisk Investigational Site
  • Israel
      • Petach Tikva, Israel, 49100
        • Novo Nordisk Investigational Site
      • Ramat Gan, Israel, 52621
        • Novo Nordisk Investigational Site
  • Italy
      • Bologna, Italy, 40138
        • Novo Nordisk Investigational Site
      • Milano, Italy, 20132
        • Novo Nordisk Investigational Site
      • San Donato Milanese (MI), Italy, 20097
        • Novo Nordisk Investigational Site
  • Japan
      • Iwate, Japan, 020-8505
        • Novo Nordisk Investigational Site
      • Osaka, Japan, 565-8565
        • Novo Nordisk Investigational Site
      • Tokyo, Japan, 113-843
        • Novo Nordisk Investigational Site
  • Spain
      • Madrid, Spain, 28034
        • Novo Nordisk Investigational Site
      • Madrid, Spain, 28007
        • Novo Nordisk Investigational Site
      • Valencia, Spain, 46026
        • Novo Nordisk Investigational Site
  • Sweden
      • Lund, Sweden, 221 85
        • Novo Nordisk Investigational Site
  • United Kingdom
      • Cambridge, United Kingdom, CB23 3RE
        • Novo Nordisk Investigational Site
      • Sheffield, United Kingdom, S5 7AU
        • Novo Nordisk Investigational Site
      • Southampton, United Kingdom, SO16 6YD
        • Novo Nordisk Investigational Site
  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30322-1059
        • Novo Nordisk Investigational Site
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Novo Nordisk Investigational Site
    • Oregon
      • Portland, Oregon, United States, 97239-3098
        • Novo Nordisk Investigational Site
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18105
        • Novo Nordisk Investigational Site
      • Philadelphia, Pennsylvania, United States, 19107
        • Novo Nordisk Investigational Site
    • Rhode Island
      • Providence, Rhode Island, United States, 02905
        • Novo Nordisk Investigational Site
    • Texas
      • Houston, Texas, United States, 77030
        • 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

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • - Planned coronary artery bypass grafting (CABG) or CABG plus single heart valve replacement/repair or planned replacement/repair of a single heart valve

Exclusion Criteria:

  • Known intolerance to protamine
  • Known or suspected allergy to the used antifibrinolytic agent
  • Refusal to receive blood or blood product
  • Planned surgery including the aortic arch and/or descending aorta
  • Planned surgery including any implantable ventricular assist device
  • Adult congenital heart diseases
  • Two or more previous cardiac surgery procedures
  • Any known autoimmune diseases: Collagen vascular disease (Systemic lupus erythematosus, Rheumatoid arthritis, Sjögrens syndrome) - Endocrine: hyperthyroidism (Graves disease), adrenal insufficiency, Hashimoto's thyroiditis - Neurologic: Multiple sclerosis, myasthenia gravis - Skin: pemphigous vulgaris Hematologic: Pernicious anaemia, Autoimmune haemolytic anaemia - Vasculitis - Primary or secondary antiphospholipid syndrome
  • Weight above 140 kg

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: FXIII17.5IU/Kg
Recombinant factor XIII at a single dose of 17.5 IU/kg lean body mass (LBM) was administered via slow i.v. push at a rate not exceeding two mL per minute.
Drug: catridecacog
Single dose via slow intravenous (i.v.) push at a rate not exceeding two mL per minute
Experimental: FXIII35IU/Kg
Recombinant factor XIII at a single dose of 35 IU/kg lean body mass (LBM) was administered via slow i.v. push at a rate not exceeding two mL per minute.
Drug: catridecacog
Single dose via slow intravenous (i.v.) push at a rate not exceeding two mL per minute
Placebo Comparator: Placebo
Recombinant factor XIII placebo was administered as a single dose via slow i.v. push at a rate not exceeding two mL per minute.
Drug: placebo
Single dose via slow intravenous (i.v.) push at a rate not exceeding two mL per minute

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Subjects Avoiding Any Allogeneic Transfusions for Seven Days Post-operative or Until Discharge, Whichever Came First
Time Frame: measured ongoing from dosing until day 7 or discharge, whichever came first
Proportion of patients avoiding blood products given via allogeneic transfusion. Blood products were defined as any of the following: RBC, platelets, FFP, fibrinogen concentrate and clotting factor(s) concentrate, including cryoprecipitate.
measured ongoing from dosing until day 7 or discharge, whichever came first

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Subjects With Thromboembolic Events
Time Frame: measured from screening until 5-7 weeks post Trial Drug Administration
Percentage of subjects with thromboembolic events (AMI, cerebrovascular thromboembolic event, peripheral artery occlusion, DVT, pulmonary embolism) until end of trial
measured from screening until 5-7 weeks post Trial Drug Administration
Percentage of Subjects With rFXIII Antibody Reaction
Time Frame: measured from screening until 5-7 weeks post Trial Drug Administration
Immunogenicity as number of subjects who manifested FXIII antibody reaction until end of trial. The percentage may be derived from the number of subjects treated with rFXIII with available antibody measurement at visit 8.
measured from screening until 5-7 weeks post Trial Drug Administration
Percentage of Subjects With Critical Adverse Events
Time Frame: measured from screening until 5-7 weeks post Trial Drug Administration
Percentage of subjects with critical adverse events (thromboembolic events (AMI, cerebrovascular thromboembolic event, peripheral artery occlusion, DVT, pulmonary embolism), renal dysfunction, re-operation and death) until end of trial
measured from screening until 5-7 weeks post Trial Drug Administration
Percentage of Subjects With Serious Adverse Events
Time Frame: measured from screening until 5-7 weeks post Trial Drug Administration
Percentage of subjects with serious adverse events until end of trial.
measured from screening until 5-7 weeks post Trial Drug 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

July 1, 2009

Primary Completion (Actual)

February 1, 2011

Study Completion (Actual)

February 1, 2011

Study Registration Dates

First Submitted

June 3, 2009

First Submitted That Met QC Criteria

June 4, 2009

First Posted (Estimate)

June 5, 2009

Study Record Updates

Last Update Posted (Actual)

March 7, 2017

Last Update Submitted That Met QC Criteria

January 23, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN1810-3540
  • JapicCTI-101078 (Registry Identifier: JAPIC)
  • 2008-006324-62 (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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