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
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- Serum HBV pgRNA change compared with baseline
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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;
排除标准
- •Chronic HBV with unexplained portal hypertension;
- •Subjects with liver cancer or serum AFP >1×ULN;
- •Previously received FXR therapy;
研究组 & 干预措施
Queue ASC42 15mg
ASC42 15mg , ih PEG-IFN α-2a and ETV for 12 weeks.
干预措施: Entecavir (Drug)
Queue ASC42 10mg
ASC42 10mg, ih PEG-IFN α-2a and ETV for 12 weeks.
干预措施: ASC42 10mg (Drug)
Queue ASC42 10mg
ASC42 10mg, ih PEG-IFN α-2a and ETV for 12 weeks.
干预措施: ih PEG-IFN α-2a (Drug)
Queue ASC42 10mg
ASC42 10mg, ih PEG-IFN α-2a and ETV for 12 weeks.
干预措施: Entecavir (Drug)
Queue ASC42 15mg
ASC42 15mg , ih PEG-IFN α-2a and ETV for 12 weeks.
干预措施: ASC42 15mg (Drug)
Queue ASC42 15mg
ASC42 15mg , ih PEG-IFN α-2a and ETV for 12 weeks.
干预措施: ih PEG-IFN α-2a (Drug)
Queue Placebo
Placebo, ih PEG-IFN α-2a and ETV for 12 weeks.
干预措施: ih PEG-IFN α-2a (Drug)
Queue Placebo
Placebo, ih PEG-IFN α-2a and ETV for 12 weeks.
干预措施: Entecavir (Drug)
Queue Placebo
Placebo, ih PEG-IFN α-2a and ETV for 12 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Serum HBV pgRNA change compared with baseline
时间窗: Week 12 of intervention\Week 24 of follow-up
Serum HBsAg change compared with baseline
时间窗: Week 12 of intervention\Week 24 of follow-up
次要结局
- 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)