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
Diagnosed with congenital FXIII deficiency requiring prophylactic treatment
Males and females of any age
You may not be if
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
Clareo Health | An Open Enrollment Study of Factor XIII Concentrate in Subjects With Congenital Factor XIII Deficiency
