Pradefovir Treatment for the Patients With Chronic Hepatitis B Virus Infections: a Phase3 Study

- Age from 18 to 65 years old, male or female.

- Meets the diagnosis and treatment standards of chronic hepatitis B( HBsAg or HBV DNA positive over 6 months, or diagnosed by liver biopsy.

- For HBeAg positive, HBV DNA equal or over 20000 IU/ml; for HBeAg negative ,HBV DNA equal or over 2000 IU/ml.

- ALT level between 1.2 ULN to 10 UNL.

- Treatment naive or experienced when any nucleos(t)ide analogs or interferons stopped over 6 months.

- Use of effective contraceptive measures if procreative potential exists.

- Written informed consent.

- Allergic to study drug,metabolite product or excipient.

- Evidence of hepatic decompensation such as Child-Pugh B or C, with previous gastroesophageal variceal haemorrhage, hepatic encephalopathy, ascites

- Suspected or confirmed hepatocellular carcinoma, or AFP>50μg/L.

- Other liver diseases (such as Chronic alcoholic hepatitis, drug-induced hepatitis, autoimmune liver disease).

- Resistant to antiviral drugs (adefovir or tenofovir).

- Concommitant disease of severe heart, blood, respiratory and central nervous system diseases.

- Chronic kidney diseases, or Ccr<60ml/min at screening.

- Abnormal hematological and biochemical parameters at screening: White blood cell count less than 3.0×109/L，or neutrophil count less than 1.5×109/L，or platelet count less than 80×109/L，or total bilirubin more than 2ULN，or the prolong of PT more than 3s.

- Positive-HCV or positive-HIV.

- Severe bone disease (such as osteomalacia, chronic osteomyelitis, osteogenesis imperfecta, rickets) or multiple fractures.

- History of pancreatitis or malignancy within 5 years (excluding cervical epithelial carcinoma, squamous epithelial carcinoma, or basal cell carcinoma of the skin that was clinically cured within 5 years of diagnosis).

- Plan to receive or have already had an organ transplant.

- Subject with disabilities as prescribed by law (blindness, deafness, deafness, deafness, mental disorders, etc.).

- History of alcohol or drug abuse within the last 1 year.

- Pregnant or lactating women.

- Participated in any clinical trial or taken any IMP (investigational medical product) within 3 months prior to the trial.

- Other cases that could not be enrolled in the judgement of the investigators.