Status:
COMPLETED
A Study of the Use of Factor XIII Concentrate in Patients With Inherited FXIII Deficiency
Lead Sponsor:
CSL Behring
Conditions:
Factor XIII Deficiency
Eligibility:
All Genders
Phase:
PHASE2
Brief Summary
Congenital deficiency of Factor XIII is an extremely rare hereditary disorder associated with potentially life-threatening bleeding. This study will evaluate the safety and recommended (best) amount o...
Eligibility Criteria
Inclusion
- Written informed consent/assent for study participation obtained before undergoing any study-specific procedures
- Documented congenital FXIII deficiency that 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)
- Positive result at screening for human immunodeficiency virus (HIV)
- Serum aspartate transaminase (AST) or serum alanine transaminase (ALT) concentration \>2.5 times the upper limit of normal
- Fibrinogen \< lower limit of normal
- Active bleeding
- 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
- Surgical procedure anticipated during the study period
- Suspected inability (e.g., language problems) or unwillingness to comply with study procedures or history of noncompliance
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00883090
Start Date
May 1 2009
End Date
April 1 2010
Last Update
January 16 2012
Active Locations (6)
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1
Study Site
Dothan, Alabama, United States, 36305
2
Study Site
Orange, California, United States, 92868
3
Study Site
San Francisco, California, United States, 94115
4
Study Site
Stockton, California, United States, 95204