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临床试验/ACTRN12619001441101
ACTRN12619001441101尚未招募未知

Discontinuing nucleos(t)ide analogue therapy for chronic hepatitis B -Is it safe and will it increase the rate of HBsAg seroconversion? A randomised pilot study

Dr Tien Huey Lim0 个研究点目标入组 40 人开始时间: 2019年10月17日最近更新:
适应症

试验速览

阶段
未知
状态
尚未招募
发起方
入组人数
40

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Randomised controlled trial
主要目的
Treatment
盲法
Open (masking not used)

入排标准

年龄范围
18 Years 至 60 Years(—)
性别
All

入选标准

  • Non-cirrhotic patients with chronic hepatitis B (CHB), on nucleos(t)ide analogue (NA) therapy for at least 2 years
  • - Age 18-60 years
  • - Normal ALT level at screening
  • - HBV DNA undetectable levels x3 (>6 months apart)
  • - HBsAg levels <100 IU/mL within the last 3 months

排除标准

  • - Patients with cirrhosis/severe fibrosis (Fibroscan >9kpa), hepatocellular carcinoma
  • - Other significant medical co-morbidities
  • - Patients who have history of significant non compliance
  • - Significant alcohol consumption (>30g/day for women and >50g/day for men)
  • - Poor venous access

研究者

发起方
Dr Tien Huey Lim

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