Factor XIII Deficiency

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

NCT00885742 | PHASE 3 | INTERVENTIONAL

Congenital deficiency of factor XIII (FXIII) 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 that will best minimize the chance of bruising and bleeding.

23 Sites

41 Participants

Recruiting

20 Years to 50 Years

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SUBMIT

Study Site

Dothan,Alabama,United States,36305

Study Site

Oakland,California,United States,94610

Study Site

Orange,California,United States,92868

Study Site

San Francisco,California,United States,94115

Study Site

Stockton,California,United States,95204

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Hartford,Connecticut,United States,06106

Study Site

Fort Meyers,Florida,United States,33908

Study

Miami,Florida,United States,33136

Study Site

Boise,Idaho,United States,83712

Study Site

South Bend,Indiana,United States,46601

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Boston,Massachusetts,United States,02115

Study Site

St. Paul,Minnesota,United States,55102

Study Site

Kansas City,Missouri,United States,64108

Study Site

Las Vegas,Nevada,United States,89015

Study Site

Lebanon,New Hampshire,United States,03756

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Newark,New Jersey,United States,07102

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Albany,New York,United States,12208

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New York,New York,United States,10021

Study Site

Chapel Hill,North Carolina,United States,27599

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Hershey,Pennsylvania,United States,17033

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Dallas,Texas,United States,75390

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Milwaukee,Wisconsin,United States,53233

Study Site

Santa Cruz de Tenerife,Spain,38009

Study Eligibility Criteria

Inclusion Criteria

* Written informed consent/assent for study participation obtained before undergoing any study-specific procedures
* Documented congenital FXIII deficiency which requires prophylactic treatment with a FXIII containing product.
* Males and females of any age with congenital FXIII deficiency
* Received full hepatitis B vaccination and/or is hepatitis B surface antibody positive

Exclusion Criteria

* Diagnosis of acquired FXIII deficiency
* Administration of a FXIII-containing product, including blood transfusions or other blood products within 4 weeks prior to the planned Day 0
* Any known congenital or acquired coagulation disorder other than congenital FXIII deficiency
* Known or suspected to have antibodies towards FXIII
* Use of any other investigational medicinal product within 4 weeks prior to the Baseline Visit (Day 0)
* Known Positivity for human immunodeficiency virus (HIV) or a positive result for HIV at the Screening Visit of this study or the FXIII study 2002 (NCT00883090).
* Serum aspartate transaminase (AST) or serum alanine transaminase (ALT) concentration \>2.5 times the upper limit of normal at the Screening Visit of this study or at the Day 56 Visit of Factor XIII Study BI71023_2002 (NCT00883090)
* Fibrinogen level less than 85% of the lower limit of normal at the Screening Visit of this study or the Factor XIII Study BI71023_2002 (NCT00883090)
* Active bleeding ≥ Common Terminology Criteria for Adverse Events (CTCAE) Grade 2 and/or ≥ moderate between the Screening and Baseline Visits
* Pregnant or breast-feeding
* Intention to become pregnant during the course of the study
* 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

Additional Studies

Additional studies can be found at ClinicalTrials.gov