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 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
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)
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
