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

Acquired Bleeding Disorder Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00914589
• Other study ID #: NN1810-3540
• Secondary ID: JapicCTI-1010782
• Status: Completed
• Phase: Phase 2
• First received: June 3, 2009
• Last updated: November 12, 2014
• Start date: July 2009
• Est. completion date: February 2011

Study information

• Verified date: November 2014
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health CanadaDenmark: Danish Medicines AgencyGermany: Federal Institute for Drugs and Medical DevicesIsrael: Israeli Health Ministry Pharmaceutical AdministrationItaly: The Italian Medicines AgencyJapan: Ministry of Health, Labour and Welfare (MHLW)Spain: Spanish Agency of MedicinesUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 479
• Est. completion date: February 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Acquired Bleeding Disorder
• Blood Coagulation Disorders
• Cardiac Surgery Requiring Cardiopulmonary Bypass
• Hemostatic Disorders

Intervention

Drug:
• catridecacog
Single dose via slow intravenous (i.v.) push at a rate not exceeding two mL per minute
• catridecacog
Single dose via slow intravenous (i.v.) push at a rate not exceeding two mL per minute
• placebo
Single dose via slow intravenous (i.v.) push at a rate not exceeding two mL per minute

Locations

Country	Name	City	State
United States	Novo Nordisk Clinical Trial Call Center	Allentown	Pennsylvania
United States	Novo Nordisk Clinical Trial Call Center	Atlanta	Georgia
United States	Novo Nordisk Clinical Trial Call Center	Durham	North Carolina
United States	Novo Nordisk Clinical Trial Call Center	Houston	Texas
United States	Novo Nordisk Clinical Trial Call Center	Philadelphia	Pennsylvania
United States	Novo Nordisk Clinical Trial Call Center	Portland	Oregon
United States	Novo Nordisk Clinical Trial Call Center	Providence	Rhode Island

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

United States,  Canada,  Denmark,  Germany,  Israel,  Italy,  Japan,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Subjects Avoiding Any Allogeneic Transfusions for Seven Days Post-operative or Until 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	No
Secondary	Percentage of Subjects With Thromboembolic Events	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	No
Secondary	Percentage of Subjects With rFXIII Antibody Reaction	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	No
Secondary	Percentage of Subjects With Critical Adverse Events	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	No
Secondary	Percentage of Subjects With Serious Adverse Events	Percentage of subjects with serious adverse events until end of trial.	measured from screening until 5-7 weeks post Trial Drug Administration	No

External Links

•   Clinical Trials at Novo Nordisk