COntrolled Interruption of Nucleos(t)Ide Analogue Treatment in Chronic Hepatitis B Infections
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 入组人数
- 156
- 试验地点
- 32
- 主要终点
- Viral control
研究概览
简要总结
In this study we will prospectively stop NA in both Caucasian and non-Caucasian patients matched for gender and age, to validate the observed host and viral parameters for future roll-out of this treatment strategy.
详细描述
An estimated 290 million people worldwide are chronically infected with the Hepatitis B Virus (HBV). One fourth of untreated patients develop progressive liver damage and are at risk of liver-related death, which can be prevented by treatment with Nucleos(t)ide Analogues (NA). These drugs efficiently suppress viral replication, but seroclearance of the virus, defined as loss of Hepatitis B surface Antigen (HBsAg), is predicted to require an average of 36 to 52 years of treatment. Cessation of NA after long-term viral suppression in patients without HBV seroclearance might reduce costs and may even increase the chance of subsequent HBsAg loss. We have recently shown in a retrospective multicentric international study, that Caucasian ethnicity and off-treatment viral control are associated with HBsAg loss after NA cessation. In this study we will prospectively stop NA in both Caucasian and non-Caucasian patients matched for gender and age, to validate the observed host and viral parameters for future roll-out of this treatment strategy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 75 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic hepatitis B
- •Under continuous NA treatment
- •>= 18 years old and <= 75 years
- •HBeAg negative at start of treatment
- •HBV DNA undetectable >36 months or <100 IU/mL >48 months
- •ALT <= 80 U/L
排除标准
- •Fibrosis >F2
- •Active coinfection with HCV, HDV or HIV
- •Pregnancy or lactation
- •Immunocompromised patients
- •Ever HCC or family history of HCC
- •Ever participated in HBV siRNA therapeutic trials
结局指标
主要结局
Viral control
时间窗: 72 weeks
Number of participants with viral control after treatment cessation
次要结局
- HBsAg loss(72 weeks)
