Cirrhosis, Liver, Hepatocellular Carcinoma (HCC), HEPATITIS B CHRONIC
Conditions
Brief summary
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.
Interventions
receive Biejia-Ruangan compound (2.0 g per dose, three times daily) in addition to standard antiviral therapy
DRUGBiejia-Ruangan compound simulant
receive Biejia-ruangan compound simulant (2.0 g per dose, three times daily) in addition to standard antiviral therapy
Sponsors
Nanfang Hospital, Southern Medical University
Shenzhen Third People's Hospital
Beijing Ditan Hospital
Beijing 302 Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* \[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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of HCC confirmed by imaging or histology at Week 96 of follow-up | From enrollment to the end of treatment at 96 weeks | Incidence of HCC confirmed by imaging or histology at Week 96 of follow-up |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Non-HCC liver-related events and other the clinical changes or incidence rates | From enrollment to the end of treatment at 96 weeks | 1. Liver-related death; 2. Incidence of non-HCC events and non-liver-related death; 3. Changes in liver function, liver fibrosis degree, and tumor markers; 4. Trends in the four diagnostic methods of traditional Chinese medicine and changes in TCM syndrome scores; 5. Incidence of adverse events (AEs) and serious adverse events (SAEs). |
Contacts
CONTACTRong Fan
Outcome results
None listed