Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
CSL Behring
Age
12–65
Sex
MALE
Healthy volunteers
Not accepted
You may be eligible if
Male subjects, 12 to 65 years old
Severe hemophilia B (FIX activity of ≤ 2%)
Subjects who have received FIX products (plasma-derived and/or recombinant FIX) for \> 150 exposure days (EDs)
No history of FIX inhibitor formation, no detectable inhibitors at Screening and no family history of inhibitors against FIX
Written informed consent for study participation
On-demand subjects only, who have experienced a minimum average of 2 non-trauma induced bleeding episodes requiring treatment with a FIX product during the previous 6 or 3 months
You may not be if
Known hypersensitivity to any FIX product or hamster protein
Known congenital or acquired coagulation disorder other than congenital FIX deficiency
HIV positive subjects with a CD4 count \< 200/mm3
Low platelet count, kidney or liver dysfunction
Recent life-threatening bleeding episode
Clareo Health | A Safety and Efficacy Study of a Recombinant Fusion Protein Linking Coagulation Factor IX With Albumin (rIX-FP) in Patients With Hemophilia B
