Phase 3 open label single arm study to evaluate efficacy and safety of FIX gene transfer with PF-06838435 (rAAV Spark100-hFIX-Padua) in adult male participants with moderately severe to severe hemophilia B (FIX:C= or -2%) (BeneGene-2)

The research study is being conducted to test the safety and effectiveness of the study drug which is a gene therapy based treatment. Researchers want to see if the drug works to prevent the bleeding episodes commonly experienced by patient with Hemophilia B and to advance science and medicine. Subjects will be asked to come to the doctors office about 20 times over 6 years. The study drug is given only once during the study period. During the first 12 weeks after receiving the study product subjects will be asked to provide blood, urine and/or semen samples between 1 and 3 times a week. The time between visits from Visit 6 to visit 20 will get longer (such as, every: 4 weeks, 6 weeks, 8 weeks, 10 weeks, 26 weeks, 52 weeks). It is possible that the subjects condition or health may improve, worsen, or stay the same because they are taking part in this study.

You may be eligible for this study if you meet the following criteria:

• Conditions:
  hemophilia,gene therapy
• Age: - 99 Years
• Gender: All