A Confirmatory Study of Hepabulin IV in HBsAg Positive Liver Transplantation Recipients

A 52-week, Multi-center, Open Label, Single Arm, Phase 3 Study to Evaluate the Efficacy and Safety of Hepabulin IV in HBsAg Positive Liver Transplantation Recipients

The purpose of this study is to Evaluate the efficacy and safety of Hepabulin IV (HBIG, a study drug) after liver transplantation.

A 52-week, Multi-center, Open label, Single arm, Phase 3 Study to Evaluate the Efficacy and Safety of Hepabulin IV in HBsAg positive Liver Transplantation recipients

Inclusion Criteria:

• HBsAg Positive candidate for HBV-related liver transplant
• Primary, single organ recipients
• written informed consent

Exclusion Criteria:

• acute renal failure, Serum creatinin >1.5*ULN
• severe cardiac disease or other significant disease
• HAV, HCV or HIV positive
• Immunoglobulin A deficiency.
• History of hypersensitivity to Human Immunoglobulin.
• History of cancer within 5 years. (without HCC)
• History of alcohol or/and drug abuse.
• History organ transplantation.
• Within 30 days, participation in another clinical trial and use of an investigational product.
• Subject suffer from any acute or chronic medical, surgical or psychiatric condition or laboratory abnormality that, may increase the risk associated with the study participation or investigational product administration, or may interfere with the interpretation of study result.