Dynamic Changes of Serum HBV RNA in Chronic Hepatitis B Patients With Low Level HBV DNA Treated With Nucleoside (Acid) Analogues
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- The decrease of HBV RNA from baseline to 48 weeks
研究概览
简要总结
Some patients with low-level viremia (LLV) are also likely to develop hepatocellular carcinoma (HCC) or other liver diseases. The relationship between HBV RNA levels and fibrosis in patients with HBV DNA negative or LLV is still lacking evidence. The purpose of this study is to observe the differences in HBV RNA levels and their association with efficacy in HBV DNA negative or LLV patients. Investigators conduct the prospective, single-center, non-randomized, observational clinical study. A total of 100 chronic hepatitis B (CHB) patients who receive antiviral therapy with nucleoside (acid) analogues for 1-3 years will be enrolled. The enrolled patients will be followed up five times to collect clinical data and record adverse events (at baseline, week 12, week 24, week 36 and week 48, respectively).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1.18 years old or above and the gender is not limited;
- •Patients who receive antiviral therapy with nucleoside (acid) analogues for 1-3 years ;
- •Patients with HBV DNA negative (HBV DNA<20 IU/ml) or LLV（HBV DNA 20-2000 IU/mL）
- •Good compliance and voluntary signing of informed consent.
排除标准
- •Patients with decompensated cirrhosis;
- •Patients co-infection with other viruses, such as hepatitis A virus, hepatitis C virus, hepatitis D virus, hepatitis E virus, HIV virus, etc.;
- •Patients with significant renal, cardiovascular, pulmonary, or neurological disease;
- •Patients have active or suspected malignancy or history of malignancy;
- •Patients who were identified not appropriate for the study by investigators.
结局指标
主要结局
The decrease of HBV RNA from baseline to 48 weeks
时间窗: 2023.8-2025.8
The investigators detect the dynamic change of HBV RNA and the decline from baseline to 48 weeks;
次要结局
- The association of HBV RNA changes with the liver stiffness;(2023.8-2025.8)
- HBV RNA undetectable rate at 48 weeks;(2023.8-2025.8)
- The association of the dynamic changes of serum HBV RNA levels with HBsAg and HBeAg levels;(2023.8-2025.8)