A Study to Investigate the Safety and Efficacy of Undiluted Intravenous Infusion of I.V.-Hepabig Inj.

Prior treatment

• Subject with history of anaphylaxis to any component of the investigational product
• Subject received estrogen or hormone replacement therapy within 3 months before screening
• Participated in another clinical study within 30 days (relative to the last dose of investigational product) before screening

Other illness

• Co-infection with Hepatitis A Virus, Hepatitis C Virus, or Human Immunodeficiency Virus
• Subject with history of malignancy within the last 5 years (excluding primary liver cancer)
• HBsAg or HBeAg or HBV DNA positive at screening
• Anti HBs titer less than below criteria at screening \<150 IU/L for subject whose HBeAg and HBV DNA were negative(-) before liver transplantation \>500 IU/L for subject whose HBeAg or HBV DNA were positive(+) before liver transplantation
• Subject with history of drug abuse

Lab values

• Clinically significant renal diseases (serum creatinine \>2.0mg/dL, anuria, renal failure or on dialysis at screening)

Other

• Pregnant or breast-feeding women
• Deficiency of Immunoglobulin A
• Hemophilia
• Subject who are determined disqualified to join clinical trials by investigator

• Aged ≥18 and \<65 years at the time of signing the consent form
• Subjects who had history of liver transplantation due to HBV-related end-stage liver disease such as cirrhosis, liver cancer and fulminant hepatic failure and received treatment for prevent hepatitis B recurrence
• HBsAg(+) before liver transplantation
• Subjects who have been received I.V.-Hepabig inj more than 3 times dose of 10,000International Unit/4weeks regimen