Serum HBV RNA Level Monitoring During Chronic Hepatitis B Virus Infection Especialy in Patients Undergoing Long-term Nucleos(t)Ide Analoguage Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 454
- 主要终点
- serum HBV RNA value in treatment naive patients with chronic HBV infection were tested by using HBV SAT
研究概览
简要总结
As an alternative biomarker of intrahepatic covalently closed circular DNA(cccDNA) transcriptional activity, hepatitis B virus(HBV)RNA may evolve during long-lasting virus-host interactionsduring chronic hepatitis B viral infection.The distribution pattern of serum HBV RNA levels in the natural course of chronic HBV infection remains unclear. Furthermore,serum HBV RNA was associated with response to NAs. So it may be another clinical surrogate marker for intrahepatic cccDNA level after long-term NAs treatment and be used to monitor NAs therapy. The aim of this study was to evaluate thelevels of HBV RNA during the natural courseof CHB and the role in distinguishingthe natural phases of HBV infection and to investigate whether serum HBV RNA level at the end of long-term NAs treatment had a similar or better predict effect on off-therapy relapse than serum HBsAg titer.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 to 70 years old,
- •no gender restriction,
- •serum HBsAg positive than 6 months,
- •can understand and sign informed consent,
- •good compliance.
排除标准
- •coinfected with other hepatotropic virus such as hepatitis C virus,hepatitis D -virus,hepatitis E and hepatitis A etc;
- •coinfected with HIV,
- •markers such as ceruloplasmin, anti-nuclear antibodies and anti-mitochondrial antibodies for co-existent autoimmune and metabolic liver diseases were positive,
- •with hepatocellular carcinoma(HCC)
- •with uncontrollable extrehepatic disease,
- •received glucocorticoid or other immune inhibitor therapy,
- •pregnancy.
结局指标
主要结局
serum HBV RNA value in treatment naive patients with chronic HBV infection were tested by using HBV SAT
时间窗: serum HBV RNA level were measured 24hs after the enrollment
serum HBV RNA level in patients with chronic HBV infection during different natural history stage were were compared. The relationship between serum HBV RNA and other viral markers,such as HBV DNA,HBeAg and HBsAg, were determined.
End of treatment serum HBV RNA levels predict the 24-month off-therapy viral rebound
时间窗: Change in serum HBV DNA levels from stopping baseline to 24 month after drug cessation was determined
End of treatment serum HBV RNA in patients after long-term nucleos(t)ide analog therapy were tested and the predictive effect of EOT HBV RNA value on 24-month off-therapy viral rebound were determined.
次要结局
- serum HBV RNA in patients receiving long-term NAs therapy were tested at different time point(48 hrs after enrollment the serun HBV RNA level were tested)
- Number of patients with evaluate HBV DNA relapse(> 20,000 IU/mL) through 96 weeks off-therapy(viral rebound rates were calculated from stopping baseline to 24 month after drug cessation)
研究者
LiangXS
Associate professor
Changhai Hospital