Clinical trial NCT02239146: Safety of rFXIII in Patients Following First Time Myocardial Revascularization Requiring Cardiopulmonary Bypass
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Acquired Bleeding Disorder
Cardiac Surgery Requiring Cardiopulmonary Bypass
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2014-09-12
Enrollment: 43
Sex: ALL
Minimum age (years): 35
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).


Eligibility criteria: 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

Primary outcomes:
measure: Incidence and severity of adverse events
timeFrame: From dosing up to 5-7 weeks ± 3 days after trial product administration
Secondary outcomes:
measure: Incidence and magnitude of laboratory abnormalities following administration of rFXIII
timeFrame: From dosing up to 5-7 weeks ± 3 days after trial product administration
measure: Incidence of antibodies to FXIII-A subunit
timeFrame: From dosing up to 5-7 weeks ± 3 days after trial product administration
measure: Incidence of anti-yeast antibodies
timeFrame: From dosing up to 5-7 weeks ± 3 days after trial product administration
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Novo Nordisk Investigational Site
state: Arizona
city: San Francisco
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Denver
country: United States
facility: Novo Nordisk Investigational Site
state: Colorado
city: Indianapolis
country: United States
facility: Novo Nordisk Investigational Site
state: Indiana
city: Camden
country: United States
facility: Novo Nordisk Investigational Site
state: New Jersey
city: Bronx
country: United States
facility: Novo Nordisk Investigational Site
state: New York
city: Bronx
country: United States
facility: Novo Nordisk Investigational Site
state: New York
city: New York
country: United States
facility: Novo Nordisk Investigational Site
state: New York
city: Cleveland
country: United States
facility: Novo Nordisk Investigational Site
state: Ohio
city: Portland
country: United States
facility: Novo Nordisk Investigational Site
state: Oregon
city: Portland
country: United States
facility: Novo Nordisk Investigational Site
state: Oregon
city: Allentown
country: United States
facility: Novo Nordisk Investigational Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Novo Nordisk Investigational Site
state: Pennsylvania
city: Houston
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Richmond
country: United States
facility: Novo Nordisk Investigational Site
state: Virginia
city: Toronto
country: Canada
facility: Novo Nordisk Investigational Site
city: København ø
country: Denmark
facility: Novo Nordisk Investigational Site
city: Hamburg
country: Germany
facility: Novo Nordisk Investigational Site
city: Lahr
country: Germany
facility: Novo Nordisk Investigational Site
city: Mainz
country: Germany
facility: Novo Nordisk Investigational Site
city: Cambridge
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: London
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Middlesborough
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Southampton
country: United Kingdom
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: 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/TH08-12-0826.