Novel Biomarkers Guided Stopping Nucleos(t)Ide Analogues After Long-term Virologic Suppression in CHB Patients: a Randomized Control Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 195
- 试验地点
- 5
- 主要终点
- Proportion of Participants With HBsAg Loss at Week 72 in Both Study Arms
研究概览
简要总结
The primary objective of this study is to evaluate hepatitis B surface antigen (HBsAg) loss in subjects who stop nucles(t)ide analogues (NAs) (Stop arm) compared to subjects who continue (Continue arm) Only subjects who already are on treatment with ETV, TDF or TAF monotherapy, and have achieved sustained virologic suppression (<20 IU/mL), HBeAg negativity, normal ALT for more than 1 year (pretreatment HBeAg + pts) or 3 years (pretreatment HBeAg - pts), plus qHBsAg <200 IU/mL, and HBV RNA or HBcrAg negativity will be included in this study. One treatment arm will stop the NAs therapy while the other treatment arm will continue the NAs therapy. Participants in the Stop arm will be monitored very closely with special focus on clinical relapse. If any participant in the Stop NAs arm exceeds one or more predefined limits for such flares or relapses, NAs treatment will be reinstituted.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-65 years of old, male or female
- •Chronic hepatitis B patients
- •Received continuous ETV, TDF or TAF therapy for at least 1 year prior to screening and at screening
- •For patients with Hepatitis B e Antigen (HBeAg)-positive at the beginning of NAs therapy, documented hepatitis B virus <20 IU/mL, HBeAg seroconversion and ALT normalization for at least 1 year prior to screening and at screening
- •For patients with HBeAg-negative at the beginning of NAs therapy, documented hepatitis B virus <20 IU/mL, and ALT normalization for at least 3 year prior to screening and at screening
- •<= 9 kPa on Fibroscan assessment
- •qHBsAg <200 IU/mL within 24 weeks prior to screening
- •HBV RNA or HBcrAg negativity within 24 weeks prior to screening
排除标准
- •Experience of IFN treatment within 1 year prior to screening
- •Known cirrhosis
- •History of decompensated liver disease
- •History of clinical hepatic decompensation in the judgement of the investigator
- •Evidence of hepatocellular carcinoma
- •Serological evidence of coinfection with human immunodeficiency virus (HIV), hepatitis C virus, or hepatitis D infection
- •Known hypersensitivity to TDF, its metabolites, or formulation excipients
- •History of malignant disease
- •Lactating females
- •Females wishing to became pregnant during the duration of the study
- •Subjects participating in another clinical trial
结局指标
主要结局
Proportion of Participants With HBsAg Loss at Week 72 in Both Study Arms
时间窗: Week 72
HBsAg loss is defined as qualitative HBsAg result changing from positive at baseline (BL) to negative at any post-baseline visit. Proportions are based on a Kaplan-Meier estimate.
次要结局
- Proportion of Participants With Sustained Disease Remission at Week 72 in Both Study Arms(Week 72)
- Proportion of Participants With Clinical Relapse at Week 72 in Both Study Arms(Week 72)
- Proportion of Participants With Virologic Relapse at Week 72 in Both Study Arms(Week 72)
- Change From Baseline in Quantitative HBsAg (IU/mL) in Both Study Arms(Week 72)