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

Study Overview
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Brief Summary
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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).

Official Title
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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

Conditions
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Cardiac Surgery Requiring Cardiopulmonary Bypass, Acquired Bleeding Disorder

Intervention / Treatment
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* Drug: catridecacog
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: rFXIII<br> | Drug: catridecacog<br>* 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).<br>|
| Placebo Comparator: Placebo<br> | Drug: placebo<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence and severity of adverse events |  | From dosing up to 5-7 weeks ± 3 days after trial product administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence and magnitude of laboratory abnormalities following administration of rFXIII |  | From dosing up to 5-7 weeks ± 3 days after trial product administration | 
| Incidence of antibodies to FXIII-A subunit |  | From dosing up to 5-7 weeks ± 3 days after trial product administration | 
| Incidence of anti-yeast antibodies |  | From dosing up to 5-7 weeks ± 3 days after trial product administration |