Safety and Pharmacokinetics of Recombinant Factor XIII in Patients With Congenital Factor Xlll Deficiency

Phase 1 Completed 11 enrolled Novo Nordisk A/S

Non-randomizedSingle-groupOpen-labelTreatment

Summary

This trial was conducted in the United States of America (USA). The aim of this trial was to investigate safety and pharmacokinetics of escalating single doses of catridecacog (recombinant factor XIII, rFXIII) in patients with congenital factor XIII deficiency.

Timeline

Start: 2003-03
Primary completion: 2003-10
Completion: 2003-10

Publications

Results Lovejoy AE, Reynolds TC, Visich JE, Butine MD, Young G, Belvedere MA, Blain RC, Pederson SM, Ishak LM, Nugent DJ. Safety and pharmacokinetics of recombinant factor XIII-A2 administration in patients with congenital factor XIII deficiency. Blood. 2006 Jul 1;108(1):57-62. doi: 10.1182/blood-2005-02-0788. Epub 2006 Mar 23.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	catridecacog	Protein / enzyme biologic	2 iu/kg	Intravenous
Subject	catridecacog	Protein / enzyme biologic	6 iu/kg	Intravenous
Subject	catridecacog	Protein / enzyme biologic	20 iu/kg	Intravenous
Subject	catridecacog	Protein / enzyme biologic	50 iu/kg	Intravenous
Subject	catridecacog	Protein / enzyme biologic	75 iu/kg	Intravenous

Safety and Pharmacokinetics of Recombinant Factor XIII in Patients With Congenital Factor Xlll Deficiency

Summary

Timeline

Publications

Drugs

Indications