Study to Evaluate Safety and Efficacy of ASC42 Combined With ETV and PEG-IFN α-2a in Subjects With HBV

Inclusion criteria

• 18-65 years old (including 18 and 65 years old);
• Chronic HBV infection confirmed by serological, etiological and clinical diagnosis (HBsAg positive for more than 6 months);
• HBV-DNA negative after nucleoside (acid) treatment;
• Laboratory test values meet the following requirements :

• Liver function : AST, ALT ≤ 3×ULN; serum total bilirubin≤2×ULN; direct bilirubin≤1.5×ULN; serum albumin≥35 g/L (blood collection is not within 2 weeks before transfusion of albumin);
• Hematology: white blood cell count>3.0×109/L, ANC>1.5×109/L; platelet>1×ULN; hemoglobin 120g/L. (No blood transfusion (including transfusion of red blood cells and platelets) and EPO, TPO, leukocyte-stimulating factor were required within 2 weeks before blood collection) ;
• Renal function: serum creatinine≤1×ULN;
• Thyroid function: TSH and T4 in normal range or thyroid function can be completely controlled ;
• Determination of serum immunoglobulin : IgM≤ULN;
• Coagulation function: International normalized ratio: INR≤1×ULN;

Exclusion criteria

• Chronic HBV with unexplained portal hypertension;
• Subjects with liver cancer or serum AFP >1×ULN;
• Previously received FXR therapy;