跳至主要内容
临床试验/NCT04779970
NCT04779970进行中(未招募)不适用

COntrolled Interruption of Nucleos(t)Ide Analogue Treatment in Chronic Hepatitis B Infections

University Hospital, Antwerp32 个研究点 分布在 1 个国家目标入组 156 人开始时间: 2021年7月28日最近更新:
适应症

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

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (32)

Loading locations...

相似试验