Efficacy and Safety of Clevudine Compared With Adefovir in Patients With HBeAg Positive Chronic Hepatitis Due to Hepatitis B Virus (QUASH 1)

Inclusion Criteria:

• Nucleoside treatment-naïve subjects of either gender, females who are non-pregnant and non-lactating, aged 16 years or older (or the legal age of consent as allowed by local regulations), with compensated hepatic function despite a diagnosis of chronic HBeAg positive hepatitis B infection (i.e., based on serological, virological and histological markers) will be eligible for this study.
• Subjects with historical biopsies used for entry will have chronic hepatic inflammatory injury at screening (Knodell HAI score ≥ 4 and modified Ishak fibrosis score ≤ 5). If applicable, subjects must cease previous treatment with any form of alpha interferon 12 months prior to baseline.
• For eligibility, subjects must meet the laboratory criteria for total bilirubin, prothrombin time, serum albumin, platelet count, absolute neutrophil count, ANA titer and have a creatinine clearance of ≥ 50 mL/min.

Exclusion Criteria:

• Subjects participating in a clinical trial or receiving an investigational agent for any reason within 60 days of baseline will be excluded.
• Subjects with clinically significant concomitant diseases will be excluded.