The purpose of this study is to assess the risk of bleeding due to failure of expected pharmacological action of CSL222 in adults with severe or moderately severe hemophilia B with detectable pretreatment AAV5 Nabs.
Considered legally an adult, as defined by country regulations.
Has congenital hemophilia B with known severe or moderately severe FIX deficiency (less than or equal to [<=] 2% of normal circulating FIX) for which the participant is on continuous routine FIX prophylaxis.
Has 2 consecutive detectable AAV5 NAb titer results between Screening and Visit L-Final using a validated AAV5 NAb assay (based on central laboratory results).
Has greater than (>) 150 previous exposure days to FIX replacement therapy.
History of FIX inhibitors or positive FIX inhibitor test at Prescreening, Screening or Visit L-Final (based on central laboratory results).
Screening or Visit L-Final laboratory values (based on central laboratory results) of total bilirubin > 2 × the upper limit of normal (ULN) (except if caused by Gilbert's syndrome).
ALT > 2 × the ULN
AST > 2 × the ULN
Single group
CSL222 (AAV5-hFIXco-Padua)
GeneticAdministered as a single IV infusion.
Annualized Bleeding Rate (ABR)
The total bleeding episodes will be analyzed. ABR is calculated as the total bleeding episodes divided by the total time at risk.
Number of participants with Treatment Emergent Adverse Events (TEAEs)
Percentage of participants with TEAEs
Number of TEAEs
Change in Liver ultrasound
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