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

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

The purpose of the study is to assess the pharmacokinetics, safety and efficacy of HepaGam B in combination with antiviral therapy for the prevention of hepatitis B virus (HBV) recurrence following HBV-related orthotopic liver transplant.

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 (Orthotopic Liver Transplant)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 (immunoglobulin A) 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