NCT00883090

A Study of the Use of Factor XIII Concentrate in Patients With Inherited FXIII Deficiency

A 12 Week, Multicenter, Pharmacokinetic and Safety Study of Human Plasma-Derived Factor XIII Concentrate in Subjects With Congenital Factor XIII Deficiency

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: CSL Behring · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

Congenital deficiency of Factor XIII is an extremely rare hereditary disorder associated with potentially life-threatening bleeding. This study will evaluate the safety and recommended (best) amount or level of Factor XIII in a patient's blood. Factor XIII Concentrate (Human) is given to people whose blood is lacking Factor XIII. Factor XIII Concentrate (Human) works by assisting your blood in the usual clotting process, thereby preventing bleeding.

Conditions

• Factor XIII Deficiency

Interventions

Type	Name	Description
BIOLOGICAL	FXIII Concentrate (Human)	Subjects will receive approximately 40 U/kg of FXIII every 28 days for 3 doses administered as a bolus intravenous (IV) injection at approximately 250 U/minute.

Timeline

• Start date: 2009-05-01
• Primary completion: 2010-04-01
• Completion: 2010-04-01
• First posted: 2009-04-17
• Last updated: 2012-01-16
• Results posted: 2012-01-16

Locations

6 sites across 2 countries: United States, Spain