A Study to Evaluate the Efficacy and Safety of Factor IX Gene Therapy With PF-06838435 in Adult Males With Moderately Severe to Severe Hemophilia B

Exclusion Criteria

• •Anti-AAVRh74var neutralizing antibodies (nAb) titer above the established threshold (ie, positive for nAb).
• •History of inhibitor to Factor IX or inhibitor detected during screening. Clinical signs or symptoms of decreased response to Factor IX
• •Hypersensitivity to Factor IX replacement product or IV immunoglobulin administration
• •History of chronic infection or other chronic disease
• •Any conditions associated with increased thromboembolic risk
• •Concurrent clinically significant major disease or condition unsuitable for participation and/or may interfere with the interpretation of study results
• •Laboratory values at screening visit that are abnormal or outside acceptable study limits
• •Current unstable liver or biliary disease
• •Currently on antiviral therapy for hepatitis B or C
• •Planned surgical procedure requiring Factor IX surgical prophylactic factor treatment 15 months from screening visit
• •Use of restricted therapies (e.g., blood products, acetylsalicylic acid \[aspirin\] or ibuprofen, other investigational therapy, and by-passing agents)
• •Previously dosed in a gene therapy research trial at any time or in an interventional clinical study within 12 weeks of screening visit
• •Active hepatitis B or C; hepatitis B surface antigen, hepatitis B virus deoxyribonucleic acid positivity, or hepatitis C virus ribonucleic acid positivity
• •Significant liver disease
• •Serological evidence of HIV1 or HIV2 infection with either CD4+ cell count \<=200 mm3 and/or a viral load \>20 copies/mL
• •Study and sponsor staff involved in the conduct of the study and their families
• •Unable to comply with study procedures
• •Sensitivity to heparin or heparin induced thrombocytopenia
• •Sensitivity to any of the study interventions, or components thereof, or drug or other allergy