Safety and Tolerability of VGB-R04 in Patients With Haemophilia B

Exclusion Criteria

• •1. Have significant underlying liver disease within the past 6 months prior to or at Screening, including but not limited to:
• •1. Preexisting diagnosis of portal hypertension;
• •2. Splenomegaly;
• •3. Encephalopathy;
• •4. Reduction of serum albumin;
• •5. Evidence of significant liver fibrosis;
• •2. Have anti-VGB-R04 neutralizing antibody titers ≥1:5;
• •3. Evidence of severe infection disease, i.e., human immunodeficiency virus (HIV) infection, syphilis, tuberculosis, etc.;
• •4. Evidence of active hepatitis B virus infection (HBV-DNA \>103 IU/ml) or hepatitis C virus infection (HCV antigen and HCV-RNA positive);
• •5. Evidence of malignant tumours or those with a previous history of malignant tumours;
• •6. Have a history of chronic infection or other chronic diseases that the Investigator considers to constitute an unacceptable risk;
• •7. Any immunodeficiency;
• •8. Participated in a gene transfer trial within the last 52 weeks or in a clinical trial with an investigational drug within the last 4 weeks;
• •9. Have used glucocorticoids, immunosuppressive drugs, or antipsychotics within the last 3 months;
• •10. Previous history of hypersensitivity or allergic reaction to any FIX products or any immunoglobulin;
• •11. Unable or unwilling to comply with the schedule of visits and study assessments described in the clinical protocol;
• •12. Any concurrent clinically significant major disease or any other condition that, in the opinion of the Investigator, makes the subject unsuitable for participation in the study.