Adefovir Dipivoxil Tablets (10mg) In Chinese Subjects With HBe Antigen Negative Chronic Hepatitis B

Inclusion Criteria

• Male or female subjects aged 18-65 years inclusive
• Documented chronic hepatitis B infection determined by the presence of serum HBsAg for at least 6 months
• Documented HBeAg negative and HBeAb positive at the screening visit and with at least a 6 months history of HBeAg negativity.
• Serum HBV DNA ≥ 104 copies/mL (Roche COBAS AMPLICORTM HBV MONITOR Test, LLOD 300 copies/mL) at study screening (within 4 weeks before baseline)
• ALT value ≥1.3 times the upper limit of normal (ULN) at the time of screening, as determined using laboratory ranges and documented ALT abnormal within 6 month prior to the study screening.
• Serum alpha fetoprotein (AFP) 1:160)
• Clinical signs of decompensated liver disease at baseline. These may include but are not limited to:

serum bilirubin > 2.5 mg/dL (≤ 43 µmol/L) - prothrombin time > 2 second prolonged above ULN

• serum albumin 10 times ULN at screening or history of acute exacerbation leading to transient decompensation
• Hepatocellular carcinoma as evidenced by one of the following:
• suspicious foci on ultrasound or radiological examination
• - where no positive ultrasound finding, but serum alpha-fetoprotein > 100ng/mL
• 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.
• Use of immunosuppressive therapy, immunomodulatory therapy (including interferon or thymosin), systemic cytotoxic agents, chronic anti-viral agents excluding lamivudine (e.g. ganciclovir, adefovir dipivoxil, entecavir, famciclovir, FTC, DAPD, LFMAU, HBIg), Chinese herbal medicines known to have activity against HBV within the previous 12 months or during the study; use of agents with effect of ALT reduction (e.g. schisandra agents) during the study
• Use of lamivudine within the previous 3 months or during the study
• Planned for liver transplantation or previous liver transplantation
• Received hepatotoxic drugs (e.g., anabolic steroids, ketaconazole, itraconazole, isoniazid, rifampin, rifabutin) within 2 months prior to study screening or expected to receive these during the course of the study.
• Received nephrotoxic drugs (e.g., aminoglycosides, amphotericin B, vancomycin, cidofovir, foscarnet, cis-platinum, pentamidine etc.) or competitors of renal excretion (e.g., probenecid) within 2 months prior to study screening or the expectation that patient will receive any of these during the course of the study.
• Receiving systemic (intravenous or oral) steroids, immuno-suppressant therapies or chemotherapeutic agents within 2 months of study screening or expected to receive these agents during the course of the study.
• History of hypersensitivity to nucleoside and/or nucleotide analogues.
• Inability to comply with study requirements.
• Lactating females or females with a positive serum pregnancy test.
• Organ or bone marrow transplant recipients.
• Previous (or planned) participation in an investigational trial involving administration of investigational compound within 2 months prior to the study screening.
• Can not comply with the requirements of the study