An Open Enrollment Study of Factor XIII Concentrate in Subjects With Congenital Factor XIII Deficiency

PHASE3CompletedINTERVENTIONAL
Enrollment

61

Participants

Timeline

Start Date

September 30, 2009

Primary Completion Date

August 31, 2011

Study Completion Date

August 31, 2011

Conditions
Factor XIII Deficiency
Interventions
BIOLOGICAL

FXIII Concentrate (Human) (FXIII)

"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 have not received at least 3 doses of FXIII Concentrate in a previous study of this product (i.e., NCT00640289, NCT00885742, or NCT00883090) will initially receive a dose of 40 U/kg by intravenous (IV) infusion."

Trial Locations (25)

10065

Study Site, New York

12208

Study Site, Albany

17033

Study Site, Hershey

27599

Study Site, Chapel Hill

33136

Study Site, Miami

33701

Study Site, St. Petersburg

33908

Study Site, Fort Myers

36301

Study Site, Dothan

37232

Study Site, Nashville

43205

Study Site, Columbus

48109

Study Site, Ann Arbor

48201

Study Site, Detroit

53223

Study site, Milwaukee

57105

Study Site, Sioux Falls

64108

Study Site, Kansas City

70121

Study Site, New Orleans

75390

Study Site, Dallas

77030

Study Site, Houston

89109

Study Site, Las Vegas

92868

Study Site, Orange

94118

Study Site, San Francisco

94609

Study Site, Oakland

95204

Study Site, Stockton

02115

Study Site, Boston

03756

Study Site, Lebanon

Sponsors

Lead Sponsor

All Listed Sponsors
lead

CSL Behring

INDUSTRY

NCT00945906 - An Open Enrollment Study of Factor XIII Concentrate in Subjects With Congenital Factor XIII Deficiency | Biotech Hunter | Biotech Hunter