Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00914589
First received: June 3, 2009
Last updated: November 12, 2014
Last verified: November 2014
  Purpose

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.


Condition Intervention Phase
Acquired Bleeding Disorder
Cardiac Surgery Requiring Cardiopulmonary Bypass
Drug: catridecacog
Drug: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Percentage of Subjects With Thromboembolic Events [ Time Frame: measured from screening until 5-7 weeks post Trial Drug Administration ] [ Designated as safety issue: No ]
    Percentage of subjects with thromboembolic events (AMI, cerebrovascular thromboembolic event, peripheral artery occlusion, DVT, pulmonary embolism) until end of trial

  • Percentage of Subjects With rFXIII Antibody Reaction [ Time Frame: measured from screening until 5-7 weeks post Trial Drug Administration ] [ Designated as safety issue: No ]
    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.

  • Percentage of Subjects With Critical Adverse Events [ Time Frame: measured from screening until 5-7 weeks post Trial Drug Administration ] [ Designated as safety issue: No ]
    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

  • Percentage of Subjects With Serious Adverse Events [ Time Frame: measured from screening until 5-7 weeks post Trial Drug Administration ] [ Designated as safety issue: No ]
    Percentage of subjects with serious adverse events until end of trial.


Enrollment: 479
Study Start Date: July 2009
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00914589

Locations
United States, Georgia
Novo Nordisk Clinical Trial Call Center
Atlanta, Georgia, United States, 30322-1059
United States, North Carolina
Novo Nordisk Clinical Trial Call Center
Durham, North Carolina, United States, 27710
United States, Oregon
Novo Nordisk Clinical Trial Call Center
Portland, Oregon, United States, 97239-3011
United States, Pennsylvania
Novo Nordisk Clinical Trial Call Center
Allentown, Pennsylvania, United States, 18105
Novo Nordisk Clinical Trial Call Center
Philadelphia, Pennsylvania, United States, 19107
United States, Rhode Island
Novo Nordisk Clinical Trial Call Center
Providence, Rhode Island, United States, 02905
United States, Texas
Novo Nordisk Clinical Trial Call Center
Houston, Texas, United States, 77030
Canada, Ontario
Toronto, Ontario, Canada, M5B 1W8
Denmark
København ø, Denmark, 2100
Germany
Berlin, Germany, 13353
Israel
Petach Tikva, Israel, 49100
Italy
San Donato Milanese (MI), Italy, 20097
Japan
Tokyo, Japan, 113-843
Spain
Madrid, Spain, 28034
United Kingdom
Cambridge, United Kingdom, CB23 3RE
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
No publications provided by Novo Nordisk A/S

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00914589     History of Changes
Other Study ID Numbers: NN1810-3540, JapicCTI-101078, 2008-006324-62
Study First Received: June 3, 2009
Results First Received: September 22, 2014
Last Updated: November 12, 2014
Health Authority: Canada: Health Canada
Denmark: Danish Medicines Agency
Germany: Federal Institute for Drugs and Medical Devices
Israel: Israeli Health Ministry Pharmaceutical Administration
Italy: The Italian Medicines Agency
Japan: Ministry of Health, Labour and Welfare (MHLW)
Spain: Spanish Agency of Medicines
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration

Additional relevant MeSH terms:
Blood Coagulation Disorders
Hemostatic Disorders
Cardiovascular Diseases
Hematologic Diseases
Hemorrhagic Disorders
Vascular Diseases

ClinicalTrials.gov processed this record on November 20, 2014