A Phase II Multi-center, Randomized, Single-blind, Placebo-controlled to Evaluate Safety and Efficacy of ASC42 Tablets in Combination With Entecavir and Pegylated Interferon α-2a in Subjects With Chronic Hepatitis B Virus
Overview
- Phase
- Phase 2
- Intervention
- Entecavir
- Conditions
- Hepatitis B, Chronic
- Sponsor
- Ascletis Pharmaceuticals Co., Ltd.
- Enrollment
- 43
- Locations
- 1
- Primary Endpoint
- Serum HBV pgRNA change compared with baseline
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief 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.
Investigators
Eligibility 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;
Arms & Interventions
Queue ASC42 15mg
ASC42 15mg , ih PEG-IFN α-2a and ETV for 12 weeks.
Intervention: Entecavir
Queue ASC42 10mg
ASC42 10mg, ih PEG-IFN α-2a and ETV for 12 weeks.
Intervention: ASC42 10mg
Queue ASC42 10mg
ASC42 10mg, ih PEG-IFN α-2a and ETV for 12 weeks.
Intervention: ih PEG-IFN α-2a
Queue ASC42 10mg
ASC42 10mg, ih PEG-IFN α-2a and ETV for 12 weeks.
Intervention: Entecavir
Queue ASC42 15mg
ASC42 15mg , ih PEG-IFN α-2a and ETV for 12 weeks.
Intervention: ASC42 15mg
Queue ASC42 15mg
ASC42 15mg , ih PEG-IFN α-2a and ETV for 12 weeks.
Intervention: ih PEG-IFN α-2a
Queue Placebo
Placebo, ih PEG-IFN α-2a and ETV for 12 weeks.
Intervention: ih PEG-IFN α-2a
Queue Placebo
Placebo, ih PEG-IFN α-2a and ETV for 12 weeks.
Intervention: Entecavir
Queue Placebo
Placebo, ih PEG-IFN α-2a and ETV for 12 weeks.
Intervention: Placebo
Outcomes
Primary Outcomes
Serum HBV pgRNA change compared with baseline
Time Frame: Week 12 of intervention\Week 24 of follow-up
Serum HBsAg change compared with baseline
Time Frame: Week 12 of intervention\Week 24 of follow-up
Secondary Outcomes
- Serum HBsAg change compared with baseline(Week 2, 4 ,8 of intervention\Week 4,12 of follow-up)
- Serum HBV pgRNA change compared with baseline(Week 2, 4 ,8 of intervention\Week 4,12 of follow-up)