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

Inclusion Criteria:

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

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

• For HBeAg positive, HBV DNA equal or over 20000 IU/ml; for HBeAg negative ,HBV DNAequal 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 stoppedover 6 months.

• Use of effective contraceptive measures if procreative potential exists.

• Written informed consent.

Exclusion Criteria:

• Allergic to study drug,metabolite product or excipient.

• Evidence of hepatic decompensation such as Child-Pugh B or C, with previousgastroesophageal 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 systemdiseases.

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

• Abnormal hematological and biochemical parameters at screening: White blood cell countless than 3.0×109/L，or neutrophil count less than 1.5×109/L，or platelet count lessthan 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, osteogenesisimperfecta, rickets) or multiple fractures.

• History of pancreatitis or malignancy within 5 years (excluding cervical epithelialcarcinoma, squamous epithelial carcinoma, or basal cell carcinoma of the skin that wasclinically 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.