KRN7000 in Chronic Hepatitis B

Inclusion Criteria: * Chronic hepatitis B (confirmed by a liver biopsy performed within 3 years prior to the screenings visit and HBV DNA in serum \>10E5 copies/ml at the screenings visit). * ALT \> 1.2 x ULN on two occasions documented within 8 weeks before initiation of treatment. * Able and likely to attend regularly for treatment and follow-up. * Written informed consent. * Adequate contraception for males and females during treatment and follow-up (written confirmation). Exclusion Criteria: * Patients with evidence of cirrhosis. * Decompensated liver disease, as marked by: bilirubin greater than 20 micromol/L or serum albumin \<35 g/L or prothrombin time greater than 3 seconds prolonged or Quick test below 70% or history of bleeding esophageal varices, ascites or hepatic encephalopathy. * Systemic IFN treatment, systemic antiviral agents, systemic corticosteroids, immune suppressive treatment or any investigational drug within 3 months of entry to this protocol. * Patients with ALT levels greater than 10 times ULN will not be enrolled but may be followed until three consecutive determinations within 2 months are below this level. * Pregnancy, or in women of child-bearing potential or in spouses of such women, inability to practice adequate contraception. * Significant systemic or major illnesses other than liver disease, including congestive heart failure, ischemic heart disease, angina pectoris, cerebrovascular disease, renal failure (creatinine clearance less than 50 ml/min), organ transplantation, serious psychiatric disease or depression, anaphylactic disorder. * Pre-existing severe cytopenia; Hb\<7 mmol/L, WBC \<3x10E9/L, Plt \<100x10E9/L, Lymphocyte \<0.5x10E9/L. * Any history or presence of autoimmune disease. * Evidence of hepatocellular carcinoma; alpha-fetoprotein (AFP) levels greater than 50 ng/ml and ultrasound (or other imaging study) within 6 months prior to the entry demonstrating a mass suggestive of liver cancer. * Human immunodeficiency virus infection, as shown by presence of anti-HIV antibody. * Patients with cerebroside metabolite abnormalities (e.g. Gaucher's disease). * Other acquired or inherited causes of liver disease: hepatitis C, hepatitis D, alcoholic liver disease, obesity induced liver disease, drug related liver disease, auto-immune liver disease, Wilson's disease, hemochromatosis, alpha-1-antitrypsin deficiency. * Any other condition which in the opinion of the investigator would make the patient unsuitable for enrollment, or could interfere with the patient participating in and completing the study.