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) \< 50 ng/mL at the first screening visit. If the AFP level is ≥ 50 ng/mL but declined to \< 50 ng/mL between screening and baseline, the patient is eligible.
• •Compensated liver disease with the following laboratory and clinical parameters at study screening:
• •* Prothrombin time ≤ 2 second above normal range.
• •* Albumin ≥ 35 g/L.
• •* Total bilirubin ≤ 2.5 mg/dL (≤ 43 µmol/L) or normal direct bilirubin.
• •* No history of variceal bleeding.
• •* No history of encephalopathy.
• •* No history of ascites
• •* Adequate renal function defined as serum creatinine ≤ 1.5 mg/dL (≤ 130 µmol/L).
• •* Adequate hematological function defined as:
• •* Absolute neutrophil count ≥ 1 x 10³/mm³ ( ≥ 1 x 10\^9/L);
• •* Platelets ≥ 80 x 10³/mm³ (≥ 80 x 10\^9/L); Platelets ≥ 100 x 10³/mm³ ( ≥ 100 x 10\^9/L) recommended for the patients who will undergo liver biopsy.
• •* Hemoglobin ≥ 10 g/dL (≥ 100 g/L) (males) or ≥ 9 g/dL (≥ 9 g/L) (females).
• •* Willing and able to undergo a minimum of two liver biopsies (prior to dosing, and after 104 weeks of therapy; only apply to subjects who are enrolled to the sites where liver biopsy is required).
• •* A female is eligible to enter and participate in this study if she is of:
• •1. non-childbearing potential (i.e., physiologically incapable of becoming pregnant, including any female who is pre-menarchal or post-menopausal);
• •2. child-bearing potential with a negative serum pregnancy test at screen, and agrees to one of the following: Complete abstinence from intercourse from 2 weeks prior to administration of the study drug, throughout the study, and for a time interval after completion or premature discontinuation from the study to account for elimination of the investigational drug, (a minimum of 5 half-lives or longer if the pharmacodynamic profile of the investigational drug warrants a longer time period); or, Female sterilization; or, Sterilization of male partner; or, Implants of levonorgestrel; or, Injectable progestogen; or, Oral contraceptive (combined or progestogen only); or, Any intrauterine device (IUD) with published data showing that the lowest expected failure rate is less than 1% per year (not all IUDs meet this criterion); or, Any other methods with published data showing that the lowest expected failure rate for that method is less than 1% per year; or, Barrier method only if used in combination with any of the above acceptable methods.
• •* Agree not to participate in any other investigational trials or to undertake other HBV systemic antiviral regimens during participation in this study
• •* Able to give written informed consent and comply with the requirements of the study