Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
CSL Behring
Age
Any age
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
