Status:
COMPLETED
A Study of Factor XIII Concentrate in Subjects With Congenital Factor XIII Deficiency
Lead Sponsor:
CSL Behring
Conditions:
Factor XIII Deficiency
Eligibility:
All Genders
Phase:
PHASE3
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2011
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT00885742
Start Date
August 1 2009
End Date
April 1 2011
Last Update
July 16 2012
Active Locations (23)
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1
Study Site
Dothan, Alabama, United States, 36305
2
Study Site
Oakland, California, United States, 94610
3
Study Site
Orange, California, United States, 92868
4
Study Site
San Francisco, California, United States, 94115