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

The purpose of this study is to evaluate the efficacy and safety of undiluted intravenous infusion of I.V.-Hepabig inj. in post-liver transplant patients

Inclusion Criteria:Aged ≥19 and ≤65 years at the time of signing the consent formHBsAg(+) before liver transplantationSubjects 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 recurrenceSubjects who have been received I.V.-Hepabig inj more than 3 times dose of 10,000International Unit/4weeks regimen, and whole duration of administration of I.V.-Hepabig ing will not be exceeded 1 year while participating this studyExclusion Criteria:Subject with history of anaphylaxis to any component of the investigational productPregnant or breast-feeding womenDeficiency of Immunoglobulin AClinically significant renal diseases (serum creatinine >2.0mg/dL, anuria, renal failure or on dialysis at screening)HemophiliaCo-infection with Hepatitis A Virus, Hepatitis C Virus, or Human Immunodeficiency VirusSubject with history of malignancy within the last 5 years (excluding primary liver cancer)Subject received estrogen or hormone replacement therapy within 3 months before screeningHBsAg or HBeAg or HBV DNA positive at screeningAnti 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 and HBV DNA were positive(+) before liver transplantationSubject with history of drug abuseParticipated in another clinical study within 30 days (relative to the last dose of investigational product) before screeningSubject who are determined disqualified to join clinical trials by investigator