Status:
COMPLETED
An Open Enrollment 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 is an extremely rare inherited disorder associated with potentially life-threatening bleeding. Factor XIII Concentrate is given to patients whose blood is lacking ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
61 Patients enrolled
Trial Details
Trial ID
NCT00945906
Start Date
September 1 2009
End Date
August 1 2011
Last Update
October 12 2012
Active Locations (25)
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1
Study Site
Dothan, Alabama, United States, 36301
2
Study Site
Oakland, California, United States, 94609
3
Study Site
Orange, California, United States, 92868
4
Study Site
San Francisco, California, United States, 94118