A Study of Factor XIII Concentrate in Subjects With Congenital Factor XIII Deficiency

PHASE3CompletedINTERVENTIONAL
Enrollment

41

Participants

Timeline

Start Date

August 31, 2009

Primary Completion Date

April 30, 2011

Study Completion Date

April 30, 2011

Conditions
Factor XIII Deficiency
Interventions
BIOLOGICAL

FXIII Concentrate (Human)

"Doses will be guided by the individual subject's most recent FXIII activity levels, with the objective of dosing every 28 days to maintain a trough FXIII activity level of approximately 5 to 20%.~Subjects enrolled in this study who did not complete the pharmacokinetic study (Factor XIII Study BI71023\_2002 \[NCT00883090\]) will initially receive FXIII Concentrate (Human) at a dose of 40 U/kg by intravenous (IV) infusion."

Trial Locations (23)

10021

Study Site, New York

12208

Study Site, Albany

17033

Study Site, Hershey

27599

Study Site, Chapel Hill

33136

Study, Miami

33908

Study Site, Fort Meyers

36305

Study Site, Dothan

38009

Study Site, Santa Cruz de Tenerife

46601

Study Site, South Bend

53233

Study Site, Milwaukee

55102

Study Site, Saint Paul

64108

Study Site, Kansas City

75390

Study Site, Dallas

83712

Study Site, Boise

89015

Study Site, Las Vegas

92868

Study Site, Orange

94115

Study Site, San Francisco

94610

Study Site, Oakland

95204

Study Site, Stockton

06106

Study Site, Hartford

02115

Study Site, Boston

03756

Study Site, Lebanon

07102

Study Site, Newark

Sponsors

Lead Sponsor

All Listed Sponsors
lead

CSL Behring

INDUSTRY

NCT00885742 - A Study of Factor XIII Concentrate in Subjects With Congenital Factor XIII Deficiency | Biotech Hunter | Biotech Hunter