Phase 3 Study of GSK548470 in Patients With Compensated Chronic Hepatitis B With Poor Response to Other Drugs

Exclusion Criteria

• •Decompensated liver disease
• •Co-infection with HIV or HCV
• •Autoimmune hepatitis rather than chronic hepatitis B
• •Subject with serious complication
• •Received or have a plan for solid organ or bone marrow transplantation
• •Has proximal tubulopathy
• •History of hypersensitivity to nucleoside and/or nucleotide analogues
• •Evidence of hepatocellular carcinoma by diagnostic imaging at screening and/or serum α-fetoprotein \> 50 ng/mL at screening
• •History of HCC
• •Received any interferon or HB vaccine therapy within 24 weeks prior to initiation
• •Received overdose NSAIDs, excluding temporary or topical use, within 7 days prior to initiation
• •Received drugs for injection containing glycyrrhizin as the main component within 4 weeks prior to initiation
• •Received drugs causing renal impairment, competitors of renal excretion, immunosuppressants, chemotherapeutics and/or corticosteroids within 8 weeks prior to initiation
• •Participation in another clinical study within 6 months of study entry or planned participation in another clinical study after entry to this study
• •Woman who is pregnant, lactating, possibly pregnant or planning a pregnancy during the study period
• •Psychiatry disorder or cognitive disorder that may affect the subject ability to give informed consent or to follow specified study procedures
• •History of alcohol or drug abuse
• •Any condition or situation that may interfere with the subject's participation in the study