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

Phase 1 Completed 43 enrolled Novo Nordisk A/S

RandomizedParallel-groupDouble-blindTreatment

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).

Timeline

Start: 2005-10
Primary completion: 2008-01
Completion: 2008-01

Publications

Results 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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	catridecacog	Protein / enzyme biologic	11.9 iu/kg	Intravenous
Subject	catridecacog	Protein / enzyme biologic	25 iu/kg	Intravenous
Subject	catridecacog	Protein / enzyme biologic	35 iu/kg	Intravenous
Subject	catridecacog	Protein / enzyme biologic	50 iu/kg	Intravenous

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

Summary

Timeline

Publications

Drugs

Indications