A Confirmatory Study of Hepabulin IV in HBsAg Positive Liver Transplantation Recipients
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Ages Eligible for Study:
18 Years to 64 Years (Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
HBsAg Positive candidate for HBV-related liver transplant
Primary, single organ recipients
written informed consent
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.