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

Phase 1

Completed

• Conditions: Acquired Bleeding Disorder; Cardiac Surgery Requiring Cardiopulmonary Bypass
• Interventions: Drug: placebo; Drug: catridecacog

• Registration Number: NCT02239146
• Lead Sponsor: Novo Nordisk A/S

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2005-10
• Primary Completion: 2008-01
• Study Completion: 2008-01
• Study First Submitted: 2014-09-10
• Study First Submitted QC: 2014-09-10
• Study First Posted: 2014-09-12
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-10
• Last Update Posted: 2017-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	placebo	-
rFXIII	catridecacog	-

Primary Outcome Measures

Name	Time	Method
Incidence and severity of adverse events	From dosing up to 5-7 weeks ± 3 days after trial product administration

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇬🇧 Southampton, United Kingdom