Effect of Fufang Biejiaruangan Combined With Antiviral Therapy on the Incidence of Hepatocellular Carcinoma in Patients With Hepatitis B-related Cirrhosis: A Multicenter, Randomized, Placebo-controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 1,034
- 主要终点
- Incidence of HCC confirmed by imaging or histology at Week 96 of follow-up
研究概览
简要总结
This study aims to establish a prospective, multicenter, randomized, double-blind, placebo-controlled parallel-group clinical trial cohort. The cohort will include high-risk populations for hepatitis B cirrhosis-related hepatocellular carcinoma (HCC) from multiple centers nationwide, who meet the criteria of traditional Chinese medicine syndrome differentiation as Qi-zhi-xue_yu syndrome and have an aMAP score >60 points. The objective is to evaluate whether combining Bie-jia-ruan-gan with standard anti-hepatitis B virus therapy can further reduce the incidence of HCC in this high-risk population.
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
- Triple (Participant, Care Provider, Investigator)
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
- •Voluntarily signed informed consent form
- •Aged 18-65 years
- •Traditional Chinese Medicine (TCM) syndrome type: Qi-zhi -xue-yu
- •Meeting the diagnostic criteria for hepatitis B-related cirrhosis
- •aMAP score > 60
排除标准
- •[Previously diagnosed with or treated for hepatocellular carcinoma (HCC) or other malignancies
- •Pregnant or lactating women
- •Decompensated cirrhosis (e.g., presence of obvious ascites, hepatic encephalopathy, or gastrointestinal bleeding)
- •Concomitant liver diseases, including but not limited to hepatitis C virus infection, human immunodeficiency virus infection, alcoholic liver disease, autoimmune liver disease, or drug-induced liver injury
- •Severe cardiac, renal, respiratory, or hematopoietic system diseases
- •Determined by the investigator to be unsuitable for participation in this trial
研究组 & 干预措施
Experimental: Standard antiviral therapy + Biejia-Ruangan compound
receive Biejia-Ruangan compound (2.0 g per dose, three times daily) in addition to standard antiviral therapy.
干预措施: Biejia-Ruangan compound (Drug)
Placebo Comparator: Standard antiviral therapy + Placebo
receive Bie-jia-ruan-gan simulant (2.0 g per dose, three times daily) in addition to standard antiviral therapy
干预措施: Biejia-Ruangan compound simulant (Drug)
结局指标
主要结局
Incidence of HCC confirmed by imaging or histology at Week 96 of follow-up
时间窗: From enrollment to the end of treatment at 96 weeks
Incidence of HCC confirmed by imaging or histology at Week 96 of follow-up
次要结局
- Non-HCC liver-related events and other the clinical changes or incidence rates(From enrollment to the end of treatment at 96 weeks)