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

• Status: Not yet recruiting
• Trial end date: 2023-02-23
• Target enrollment: 0
• Participant gender: All

Summary

This is a phase2, randomized, single-blind, placebo controlled and multi-center study in adults with chronic hepatitis B virus. The study is aimed at evaluating efficacy and safety of ASC42 in combination with entecavir and pegylated interferon α-2a in subjects with chronic hepatitis B virus.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ascletis Pharmaceuticals Co., Ltd.
• Treatments: Entecavir

Criteria

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;