A Two-year Study of Telbivudine in HBeAg Negative Hepatitis

• Detectable serum HBsAg at the Screening visit and at least 6 months prior
• HBeAg negative at Screening visit
• serum HBV DNA level >2,000 IU/mL at Screening visit
• Elevated serum ALT≥2 ×ULN and \<10×ULN at Screening visit (excluding ALT elevations due to non-HBV reasons such as drug, alcohol etc)

Exclusion Criteria:

• Patient has a history of clinical signs/symptoms of hepatic decompensation (Child-Pugh Grade B or C) or ascites, esophageal variceal bleeding, hepatic encephalopathy, or spontaneous bacterial peritonitis.
• Patient has a history of hepatocellular carcinoma (HCC) or suspected symptoms of HCC, such as suspicious foci on imaging studies and/or serum alpha-fetoprotein (AFP)>50ng/mL.
• Patient has received treatment of nucleoside or nucleotide drugs whether approved or investigational before.
• Patient has received IFN or other immunomodulatory treatment within 52 weeks before Screening.
• Patient has a medical condition that requires frequent use of systemic acyclovir or famciclovir.
• Patient has a medical condition that requires frequent use of systemic corticosteroids, however topical and inhaled corticosteroids are allowed.
• Patient has used hepatotoxic drugs within one month.
• Patient has overtaken alcohol (>40g/day) or abused illicit drugs in recent one year.
• Use of other investigational drugs at the time of enrollment.
• History of hypersensitivity to any of the study drugs (telbivudine or adefovir).
• Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive urine pregnancy test.
• Patient is co-infected with HCV, HDV or HIV.
• Patient has one or more additional known primary or secondary causes of liver disease, other than hepatitis B (e.g., alcoholism, autoimmune hepatitis).
• History of malignancy of any organ system.