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

Novo Nordisk A/S43 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Acquired Bleeding Disorder Cardiac Surgery Requiring Cardiopulmonary Bypass

Interventions

catridecacogDRUG

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).

placeboDRUG

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).

Eligibility

Sex: ALLMin age: 35 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (24)

Novo Nordisk Investigational Site

Tucson, Arizona, United States

Outcomes

Primary Outcomes

Incidence and severity of adverse events

Time frame: From dosing up to 5-7 weeks ± 3 days after trial product administration

Secondary Outcomes

Incidence and magnitude of laboratory abnormalities following administration of rFXIII

Time frame: From dosing up to 5-7 weeks ± 3 days after trial product administration

Incidence of antibodies to FXIII-A subunit

Time frame: From dosing up to 5-7 weeks ± 3 days after trial product administration

Incidence of anti-yeast antibodies

Time frame: From dosing up to 5-7 weeks ± 3 days after trial product administration

Data from ClinicalTrials.gov

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