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

A Phase 3, Multicenter, Open Label Study to Assess the Safety and Efficacy of Nabi-HB Administered Subcutaneously in Patients With Hepatitis B Virus Associated Liver Disease Who Underwent Liver Transplantation

A phase 3, multicenter, open label study to assess the safety and efficacy of Nabi-HB, administered subcutaneously in patients with Hepatitis B Virus Associated Liver Disease who underwent liver transplantation.

This is a phase 3 prospective, single arm open label study to be conducted t approximately 4 study sited located in th e USA. Approximately 25 HBV DNA negative patients who underwent liver transplant at least one year prior, due to chronic hepatitis B infection will bwe eligible for study participation. The study consist of a total of 16 study visit and the duration of participation will be 20 weeks for each patients. Patients will be converted from the intravenous standard HBIG to Nabi-HB subcutaneous administration according to the individual scheduled dosing interval.

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.