New Combination of ETV, TQ-A3334 and TQ-B2450 for the Treatment of Chronic Hepatitis B Virus Infection
试验速览
- 阶段
- 2 期
- 入组人数
- 30
- 主要终点
- Change from baseline in HBsAg quantification at week 24
研究概览
简要总结
This study is a single-center, randomized, prospective, open-label Phase 2 Clinical trial to evaluate efficacy and safety of ETV and TQ-A3334 combinated with/without inhibitor of TQ-B2450 versus ETV alone in chronic hepatitis B patients. Patients were randomized to one of 3 different antiviral treatment.
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
- None
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
- •Male and female patients from 18 to 65 years of age;
- •Chronic hepatitis B infection
- •Negative urine or serum pregnancy test (for women of childbearing potential) documented within the 24-hour period prior to the first dose of test drug;
- •Agree to participate in the study and sign the patient informed consent.
排除标准
- •Patients who had NAs resistance;
- •Other antiviral, anti-neoplastic or immunomodulatory treatment;
- •Women with ongoing pregnancy or breast-feeding;
- •Co-infection with active hepatitis A, hepatitis C, hepatitis D(Those hospitals which have the ability to do the test will do) and/or human immunodeficiency virus (HIV);
- •ALT >10 ULN;
- •LSM >9kPa ;
- •History or other evidence of a medical condition associated with chronic liver disease other than viral hepatitis (e.g., hemochromatosis, autoimmune hepatitis, metabolic liver disease, alcoholic liver disease, toxin exposures, thalassemia);
- •Signs or symptoms of hepatocellular carcinoma;
- •Neutrophil count < 1500 cells/mm3 or platelet count <90,000 cells/mm3 at screening;
- •Hemoglobin < 11.5 g/dL for females and <12.5 g/dL for men;
- •Serum creatinine level > 1.5 ULN in screening period.
- •Phosphorus < 0.65 mmol/L;
- •ANA > 1:100;
- •History of severe psychiatric disease;
- •History of a severe seizure disorder or current anticonvulsant use;
- •History of immunologically mediated disease, (e.g., inflammatory bowel disease, idiopathic thrombocytopenic purpura, lupus erythematosus, autoimmune hemolytic anemia, scleroderma, rheumatoid arthritis etc.);
- •History of chronic pulmonary disease associated with functional limitation;
- •Diseases that IFN and Nucleotides or nucleosides are not suitable.
研究组 & 干预措施
Experienced:ETV+TQ-A3334+TQ-B2450
Entecavir 0.5 mg po daily plus TQ-A3334 plus TQ-B2450 for 24 weeks in treatment experienced patients
干预措施: ETV (Drug)
Naive:ETV
Entecavir 0.5 mg po daily for 24 weeks in naive patients
干预措施: ETV (Drug)
Naive:ETV+TQ-A3334
Entecavir 0.5 mg po daily plus TQ-A3334 for 24 weeks in naive patients
干预措施: ETV (Drug)
Naive:ETV+TQ-A3334
Entecavir 0.5 mg po daily plus TQ-A3334 for 24 weeks in naive patients
干预措施: TQ-A3334 (Drug)
Naive:ETV+TQ-A3334+TQ-B2450
Entecavir 0.5 mg po daily plus TQ-A3334 plus inhibitor of TQ-B2450 for 24 weeks in naive patients
干预措施: ETV (Drug)
Naive:ETV+TQ-A3334+TQ-B2450
Entecavir 0.5 mg po daily plus TQ-A3334 plus inhibitor of TQ-B2450 for 24 weeks in naive patients
干预措施: TQ-A3334 (Drug)
Naive:ETV+TQ-A3334+TQ-B2450
Entecavir 0.5 mg po daily plus TQ-A3334 plus inhibitor of TQ-B2450 for 24 weeks in naive patients
干预措施: TQ-B2450 (Drug)
Experienced:ETV
Entecavir 0.5 mg po daily for 24 weeks in treatment experienced patients
干预措施: ETV (Drug)
Experienced:ETV+TQ-A3334
Entecavir 0.5 mg po daily plus TQ-A3334 for 24 weeks in treatment experienced patients
干预措施: ETV (Drug)
Experienced:ETV+TQ-A3334
Entecavir 0.5 mg po daily plus TQ-A3334 for 24 weeks in treatment experienced patients
干预措施: TQ-A3334 (Drug)
Experienced:ETV+TQ-A3334+TQ-B2450
Entecavir 0.5 mg po daily plus TQ-A3334 plus TQ-B2450 for 24 weeks in treatment experienced patients
干预措施: TQ-A3334 (Drug)
Experienced:ETV+TQ-A3334+TQ-B2450
Entecavir 0.5 mg po daily plus TQ-A3334 plus TQ-B2450 for 24 weeks in treatment experienced patients
干预措施: TQ-B2450 (Drug)
结局指标
主要结局
Change from baseline in HBsAg quantification at week 24
时间窗: week 24
HBsAg quantification are measured
次要结局
- HBsAg loss rates at week 24(week 24)
- HBsAg seroconversion rates at week 24(week 24)
- HBeAg loss rates at week 24(week 24)
- HBeAg seroconversion rates at week 24(week 24)
- HBV DNA<20IU/mL rates at week 24(week 24)
研究者
Qin Ning
Director, Head of Department of Infectious Diseases
Tongji Hospital