Virological Response After Cessation of Long Term Anti-HBV Nucleos(t)Ide Analogues (NAs) vs. Keeping on NAs Among Chronic Hepatitis B (CHB) Patients
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 2,000
- 试验地点
- 1
- 主要终点
- Incidence of HBsAg clearance
研究概览
简要总结
To Identify the collected cases who can stop NAs safely with satisfactory clinical outcome including sustain viral remission and HBsAg clearance among chronic hepatitis B(CHB) patients.
详细描述
Nucleos(t)ides analogues(NAs) is a safe and effective treatment among chronic hepatitis B(CHB) patients with excellent tolerance. Entecavir or tenofovir mono therapy has been shown to achieve inhibition of HBV replication in almost all adherent patients. However, HBsAg loss rate is low even after long-term NAs treatment. Recent studies indicated that cessation of NAs treatment could increase HBsAg clearance rate. Identifying the collected cases who can stop NAs safely with satisfactory clinical outcome including sustain viral remission and HBsAg clearance is very important.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HBsAg positive, HBeAg negative, antibody to HBeAg-positive;
- •Stable administration of anti-HBV neucleos(t)ides analogue mono therapy for at least more than one and a half year;
- •Demonstration of undetectable HBV DNA on three occasions, each at least 6 months apart, which is consistent with the APASL stopping rule;
- •Patients read, understand the consent form, and signed the study consent.
排除标准
- •Patient with other liver diseases;
- •Patient with concurrent hepatitis viruses or HIV infection;
- •Patients are reluctant to stop their anti-HBV treatment.
研究组 & 干预措施
Cessation of NAs treatment
Chronic hepatitis B patients who meet the criteria to stop the current anti-HBV Neucleos(t)ides treatment will stop their NAs at the baseline of the clinical trial.
干预措施: Stop current treatment (anti-HBV neucleos(t)ides) (Drug)
Keep on current NAs treatment
Chronic hepatitis B patients who meet the criteria to stop anti-HBV Neucleos(t)ides treatment will choose to keep on their current NAs treatment from the baseline of the clinical trial.
干预措施: Keep current treatment (anti-HBV neucleos(t)ides) (Drug)
结局指标
主要结局
Incidence of HBsAg clearance
时间窗: From baseline to the end of the fifth year after cessation of anti-HBV treatment.
The incidence of HBsAg clearance during the off-treatment period
次要结局
- Incidence of Liver failure(rom baseline to the end of the fifth year after cessation of anti-HBV treatment.)
- Incidence of HBsAg seroconversion(From baseline to the end of the fifth year after cessation of anti-HBV treatment.)
- Incidence of sustain biological response(rom baseline to the end of the fifth year after cessation of anti-HBV treatment.)
- Incidence of hepatocellular carcinoma(rom baseline to the end of the fifth year after cessation of anti-HBV treatment.)
- Incidence of sustain HBV viral submission(rom baseline to the end of the fifth year after cessation of anti-HBV treatment.)