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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


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
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