HepeX-B in Post Hepatic Allografts for Treatment of End Stage Liver Disease Due to Hepatitis B Infection

Inclusion Criteria

• •Male and female patients who are 18 years of age or older,
• •Patients who are at least 6 months post first orthotopic liver transplantation (living or cadaveric donor) for treatment of end-stage liver disease due to HBV infection,
• •Patients who have received HBIg since transplantation and are on a stable regimen (i.e., same dose and frequency) for at least the 3 months immediately preceding study entry (Day 1),
• •Patients who have received treatment with an inhibitor of HBV polymerase for at least the 3 months immediately preceding study entry (Day 1),
• •Patients with undetectable HBsAg and HBV DNA concentrations on two consecutive tests at least 1 week apart during the screening period,
• •Female patients who are of childbearing potential, and males whose partners are women of childbearing potential, are required to use adequate contraception, and
• •Patients who are able to provide written informed consent.
• •Patients who successfully complete the initial 20-week treatment in the core trial are eligible for the 52-week extension phase.