Factor XIII Deficiency

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

NCT00945906 | PHASE 3 | INTERVENTIONAL

Congenital deficiency of factor XIII is an extremely rare inherited disorder associated with potentially life-threatening bleeding. Factor XIII Concentrate is given to patients whose blood is lacking factor XIII. Factor XIII Concentrate works by assisting blood in the usual clotting process, thereby preventing bleeding. In this study, patients will be treated with FXIII Concentrate (Human) and followed closely to determine that they receive the dose of FXIII Concentrate (Human) that will best minimize the chance of bruising and bleeding. The purpose of the study is to provide FXIII Concentrate (Human) to patients until the product becomes commercially available in the United States.

25 Sites

61 Participants

Recruiting

18 Years to 17 Years

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Find closest sites:

SUBMIT

Study Site

Dothan,Alabama,United States,36301

Study Site

Oakland,California,United States,94609

Study Site

Orange,California,United States,92868

Study Site

San Francisco,California,United States,94118

Study Site

Stockton,California,United States,95204

Study Site

Fort Myers,Florida,United States,33908

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Miami,Florida,United States,33136

Study Site

St. Petersburg,Florida,United States,33701

Study Site

New Orleans,Louisiana,United States,70121

Study Site

Boston,Massachusetts,United States,02115

Study Site

Ann Arbor,Michigan,United States,48109

Study Site

Detroit,Michigan,United States,48201

Study Site

Kansas City,Missouri,United States,64108

Study Site

Las Vegas,Nevada,United States,89109

Study Site

Lebanon,New Hampshire,United States,03756

Study Site

Albany,New York,United States,12208

Study Site

New York,New York,United States,10065

Study Site

Chapel Hill,North Carolina,United States,27599

Study Site

Columbus,Ohio,United States,43205

Study Site

Hershey,Pennsylvania,United States,17033

Study Site

Sioux Falls,South Dakota,United States,57105

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Nashville,Tennessee,United States,37232

Study Site

Dallas,Texas,United States,75390

Study Site

Houston,Texas,United States,77030

Study site

Milwaukee,Wisconsin,United States,53223

Study Eligibility Criteria

Inclusion Criteria

* Written informed consent/assent for study participation obtained before undergoing any study specific procedures
* Diagnosed with congenital FXIII deficiency requiring prophylactic treatment
* Males and females of any age

Exclusion Criteria

* Diagnosis of acquired FXIII deficiency
* Administration of a FXIII-containing product, including blood transfusions or other blood products, within 3 weeks prior to the Baseline/Day 0 Visit
* Any known congenital or acquired coagulation disorder other than congenital FXIII deficiency
* Use of any other IMP within 4 weeks prior to Baseline/Day 0 Visit
* Female subjects of childbearing potential not using, or not willing to use, a medically reliable method of contraception for the entire duration of the study
* Suspected inability (e.g., language problems) or unwillingness to comply with study procedures or history of noncompliance
* Any laboratory finding or medical condition which, in the opinion of the Investigator, would put the subject or subject's disease management at risk

Additional Studies

Additional studies can be found at ClinicalTrials.gov