Nabi-HB Administered Subcutaneously in Patients With Hepatitis B Virus Post Liver Transplantation

Inclusion Criteria:

• Male or female patients 18 years old or older as of visit one.

• If female is not trying to conserve, not lactating, and has a negative serum pregnancy test and use an acceptable method of contraception or be at least one year post-menopausal or surgically sterile.

• Able to provide written informed consent.

• First time liver transplant recipient.

• Primary, single organ recipient (deceased donor <65 years old).

• receive regular long-term HBIG prophylaxis with stabilized HBIG dosage and administration intervals.

• Have negative quantifiable HBV-DNA and HBsAg results prior to dosing at visit 2.

• Following the last IV administration of HBIG, have a baseline serum anti-HBs level of >150 IU/ML prior to dosing at visit 2.

Exclusion Criteria

• Positive HCV or HIV test results.

• Unexplained elevated liver function tests.

• Serum creatinine level >2.0 times the upper limit of normal.

• life expectancy <6 months.

• liver transplantation with ongoing acute rejection episode. Donor liver that was from a hepatitis Bor C positive donor. Underwent a liver transplant <12 months prior to visit 1.

• Know history of cancer, suspected cancer, or cancer therapy within 12 months.

• History of autoimmune disease.

• History/current evidence of coagulation disorder, severe cardiac disease, unhealed gastric or duodenal ulcer, or other significant disease.

• Evidence of any other unresolved infection and any unresolved opportunistic infection requiring treatment.

• Known immunoglobulin A deficiency.

• History of use of immunosupressive or immunomodulatory drug within 3 month prior to visit 1. (except low dose glucocorticoid therapy, <10 mg of prednisone or equivalent per day.)

• received and investigational drug 30 days prior to visit 1.

• use of plasma preparations or other immunoglobulins during the study.

• Know intolerance to proteins of human origin, immunoglobulin, or comparable products.

• Evidence of alcohol and/or drug abuse within 6 month of visit 2 or inability/unwillingness to abstain from alcohol for the duration of the study.