An Open Label, Multi Centre Phase IV Study of Adefovir Dipivoxil in Korean Patients With Chronic Hepatitis B (CHB)

Exclusion Criteria

• •A subject will not be eligible for inclusion in this study if any of the following criteria apply:
• •1. Use of immunosuppressive therapy requiring use of more than 5mg of prednisone(or equivalent) per day, immunomodulatory therapy (including interferon or thymosin ) or systemic cytotoxic agents within previous 6 months or during the study
• •2. Previous or current lamivudine or adefovir dipivoxil therapy or antiviral therapy with agents demonstrating potential anti-HBV activity
• •3. Clinical signs of decompensated liver disease at screening according to the protocol
• •4. Serum creatinine over 1.5mg per dL
• •5. Alanine aminotransferase (ALT) over 10 times ULN at screening or history of acute exacerbation leading to transient decompensation
• •6. Serum Amylase and/or lipase over 2 times ULN
• •7. Inadequate haematological function
• •8. Anti-HBe or Anti-HBs positive subjects
• •9. Hepatocellular carcinoma as evidenced by the protocol
• •10. Documented evidence of active liver disease
• •11. Any serious or active medical or psychiatric illnesses other than hepatitis B which, in the opinion of the investigator, would interfere with patient treatment, assessment or compliance with the protocol. This would include any uncontrolled clinically significant renal, cardiac, pulmonary, vascular, neurogenic, digestive, metabolic (diabetes, thyroid disorders, adrenal disease), immunodeficiency disorders or cancer.
• •12. Active alcohol or drug abuse or history of alcohol or drug abuse considered by the investigator to be sufficient to hinder compliance with treatment, participation in the study or interpretation of results.
• •13. Planned for liver transplantation or previous liver transplantation
• •14. Receipt of any investigational drug within within 3 months prior to screening.
• •15. Therapy with nephrotoxic drugs or competitors of renal excretion within 2 months prior to study screening or the expectation that patient will receive any of these during the course of the study.
• •16. History of hypersensitivity to nucleoside and/or nucleotide analogues.
• •17. Inability to comply with study requirements as determined by the study investigator.