Evaluation of HepaGam B® in Combination With Antiviral Treatment in Hepatitis B Liver Transplant Patients

Inclusion Criteria:

- Written informed consent

- HBsAg-positive candidates for HBV-related liver transplant

- Treatment with antiviral therapy before transplantation as per treating physician's
recommendation. (NOTE: It is expected that most patients will receive Lamivudine or
Adefovir Dipivoxil pre-transplant. In the case of antiviral resistance, an effective
alternative antiviral agent(s) must be used.)

Exclusion Criteria:

- Multi-organ transplantation recipients

- Liver re-transplantation except for primary non-function

- Presence of a hepatoma (larger than 5.0 cm as a solitary node) or 2 to 3 multi-focal
nodes (larger than 3.0 cm each) (Milan Criteria) based on information available at
baseline visit (CT scan, MRI).

- Patients requiring an OLT due to fulminant hepatitis B

- OLT patients receiving a liver graft from a donor that is positive for HBsAg

- Patients using interferon pre-transplant (as interferon cannot be used
post-transplant)

- History of IgA deficiency

- History of hypersensitivity to blood products.

- HIV or HCV positive

- Use of an investigational product, or participation in another clinical trial during
the course of the study (with the exception of quality-of-life or repository studies)

- Pregnancy or planned pregnancy during the course of the study