NCT02239146

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: All
• Age: 35 Years – 70 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Acquired Bleeding Disorder
• Cardiac Surgery Requiring Cardiopulmonary Bypass

Interventions

Type	Name	Description
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).
DRUG	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).

Timeline

• Start date: 2005-10-01
• Primary completion: 2008-01-01
• Completion: 2008-01-01
• First posted: 2014-09-12
• Last updated: 2017-01-11

Locations

24 sites across 5 countries: United States, Canada, Denmark, Germany, United Kingdom