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

Acquired Bleeding Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02239146
• Other study ID #: F13CARD-1660
• Secondary ID: 2005-000729-40
• Status: Completed
• Phase: Phase 1
• First received: September 10, 2014
• Last updated: January 10, 2017
• Start date: October 2005
• Est. completion date: January 2008

Study information

• Verified date: January 2017
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines AgencyGermany: Paul-Ehrlich-InstitutUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: January 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 70 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

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

Intervention

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).
• 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).

Locations

Country	Name	City	State
Canada	Novo Nordisk Investigational Site	Toronto
Denmark	Novo Nordisk Investigational Site	København ø
Germany	Novo Nordisk Investigational Site	Hamburg
Germany	Novo Nordisk Investigational Site	Lahr
Germany	Novo Nordisk Investigational Site	Mainz
United Kingdom	Novo Nordisk Investigational Site	Cambridge
United Kingdom	Novo Nordisk Investigational Site	London
United Kingdom	Novo Nordisk Investigational Site	Middlesborough
United Kingdom	Novo Nordisk Investigational Site	Southampton
United States	Novo Nordisk Investigational Site	Allentown	Pennsylvania
United States	Novo Nordisk Investigational Site	Bronx	New York
United States	Novo Nordisk Investigational Site	Bronx	New York
United States	Novo Nordisk Investigational Site	Camden	New Jersey
United States	Novo Nordisk Investigational Site	Cleveland	Ohio
United States	Novo Nordisk Investigational Site	Denver	Colorado
United States	Novo Nordisk Investigational Site	Houston	Texas
United States	Novo Nordisk Investigational Site	Indianapolis	Indiana
United States	Novo Nordisk Investigational Site	New York	New York
United States	Novo Nordisk Investigational Site	Philadelphia	Pennsylvania
United States	Novo Nordisk Investigational Site	Portland	Oregon
United States	Novo Nordisk Investigational Site	Portland	Oregon
United States	Novo Nordisk Investigational Site	Richmond	Virginia
United States	Novo Nordisk Investigational Site	San Francisco	California
United States	Novo Nordisk Investigational Site	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

United States,  Canada,  Denmark,  Germany,  United Kingdom, 

References & Publications (1)

Levy JH, Gill R, Nussmeier NA, Olsen PS, Andersen HF, Booth FV, Jespersen CM. Repletion of factor XIII following cardiopulmonary bypass using a recombinant A-subunit homodimer. A preliminary report. Thromb Haemost. 2009 Oct;102(4):765-71. doi: 10.1160/TH0 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence and severity of adverse events		From dosing up to 5-7 weeks ± 3 days after trial product administration	No
Secondary	Incidence and magnitude of laboratory abnormalities following administration of rFXIII		From dosing up to 5-7 weeks ± 3 days after trial product administration	No
Secondary	Incidence of antibodies to FXIII-A subunit		From dosing up to 5-7 weeks ± 3 days after trial product administration	No
Secondary	Incidence of anti-yeast antibodies		From dosing up to 5-7 weeks ± 3 days after trial product administration	No

External Links

•   Clinical Trials at Novo Nordisk