Effect of Babao Dan Capsule 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
- Hepatocellular carcinoma incidence in high-risk patients with hepatitis B-related cirrhosis during a 96-week 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 Shi-re-du-yun syndrome and have an aMAP score >60 points. The objective is to evaluate whether combining Babao Dan Capsule 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 of Shi-re-du-yun
- •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 + Babao Dan Capsule
receive Babao Dan Capsule (0.6 g per dose, three times daily) in addition to standard antiviral therapy.
干预措施: Babao Dan Capsule (Drug)
Placebo Comparator: Standard antiviral therapy + Placebo
receive Babao Dan Capsule simulant (0.6 g per dose, three times daily) in addition to standard antiviral therapy.
干预措施: Babao Dan Capsule simulant (Drug)
结局指标
主要结局
Hepatocellular carcinoma incidence in high-risk patients with hepatitis B-related cirrhosis during a 96-week follow-up
时间窗: From enrollment to the end of treatment at 96 weeks
次要结局
- Incidence of hepatic decompensation events(From enrollment to the end of treatment at 96 weeks)
- Trends in the four diagnostic methods of traditional Chinese medicine(From enrollment to the end of treatment at 96 weeks)
- Incidence of adverse events (AEs)(From enrollment to the end of treatment at 96 weeks)
- Incidence of serious adverse events (SAEs).(From enrollment to the end of treatment at 96 weeks)
- FIB-4 index(From enrollment to the end of treatment at 96 weeks)
- aspartate aminotransferase (AST)(From enrollment to the end of treatment at 96 weeks)
- alanine aminotransferase (ALT)(From enrollment to the end of treatment at 96 weeks)
- alpha-fetoprotein (AFP)(From enrollment to the end of treatment at 96 weeks)