The Efficacy and Safety of ZS801 in Chinese Hemophilia B Patients.

Exclusion Criteria

• •1. Hypersensitivity to any component of the study drug (including immunosuppressants) or a condition that can not use;
• •2. Inability to tolerate immunosuppressants or steroid drugs;
• •3. Have FIX inhibitor as assessed by laboratory; or documented history of FIX inhibitor;
• •4. Who have a history or are currently suffering from any of the following serious clinical diseases:
• •1. History of malignancy or current presence of any malignancy;
• •2. Have active autoimmune disease;
• •3. Severe heart disease, including angina pectoris, myocardial infarction, heart failure, clinically significant congenital heart disease, heart valve disease, arrhythmia and atrioventricular block, etc.;
• •4. Have underlying liver disease or history of liver disease (such as portal hypertension, ascites, splenomegaly, esophageal varices, hepatic encephalopathy or hepatic fibrosis);
• •5. Have HBsAg positive or HCV-Ab positive, or are currently receiving hepatitis B or hepatitis C antiviral therapy;
• •6. Diabetes mellitus that is poorly controlled after drug treatment;
• •7. Uncontrolled hypertension or hypotension;
• •5. laboratory values:
• •1. Hemoglobin\<110g/L;
• •2. Platelets\<100×10\^9/L;
• •3. aspartate aminotransferase, Alanine transaminase, alkaline phosphatase\>2×ULN;
• •4. Total bilirubin\>1.5×ULN;
• •5. Creatinine\>ULN;
• •6. Albumin\<LLN;
• •7. HIV antibody positive or Treponema pallidum antibody positive.
• •6. Have AAV5 capsid neutralizing antibody titers \>1:640;
• •7. Those who have received clinical trials of gene therapy before screening, or have used FIX clinical trial drugs within 1 month, or participated in other drug/device clinical trials within 3 months, or plan to participate in other clinical trials during this study;
• •8. Those who have planned surgery within 52 weeks after the infusion;
• •9. Those who lost more than 400 mL of blood within 3 months before screening;
• •10. Those with epilepsy, history of mental illness (such as schizophrenia, depression, mania or anxiety) or obvious mental disorder, incapacitated or incapacitated by other reasons;
• •11. Patients with a history of drug abuse or alcoholism;
• •12. Investigators believe that subjects have poor compliance or are expected to be less likely to complete follow-up;
• •13. There are clinically significant diseases or other reasons that the researcher and/or collaborators consider unsuitable to participate in this researcher.