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

Factor XIII Deficiency Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

Factor XIII Deficiency

Clinical Trial Details

NCT number	NCT00883090
Study type	Interventional
Source	CSL Behring
Contact
Status	Completed
Phase	Phase 2
Start date	May 2009
Completion date	April 2010

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT00945906` - An Open Enrollment Study of Factor XIII Concentrate in Subjects With Congenital Factor XIII Deficiency	Phase 3
Recruiting	`NCT01106937` - Factor XIII and Pulmonary Embolism in Neurosurgical Patients	N/A
Completed	`NCT03523624` - Factor XIII and Other Biomarkers in ST Segment Elevation Myocardial Infarction
Not yet recruiting	`NCT03188913` - Factor XIII in Major Burns Coagulation	N/A
Completed	`NCT00735579` - Wound Healing Abnormalities in Major Abdominal Surgery	N/A
Completed	`NCT00640289` - Clinical Trial of Factor XIII (FXIII) Concentrate	N/A
Completed	`NCT00885742` - A Study of Factor XIII Concentrate in Subjects With Congenital Factor XIII Deficiency	Phase 3