Cirrhosis, Liver, HEPATITIS B CHRONIC, Hepatocellular Carcinoma (HCC)
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 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.
Interventions
DRUGBabao Dan Capsule
receive compound Babao Dan Capsule (0.6 g per dose, three times daily) in addition to standard antiviral therapy.
DRUGBabao Dan Capsule simulant
receive compound Babao Dan Capsule simulant (0.6 g per dose, three times daily) in addition to standard antiviral therapy.
Sponsors
Nanfang Hospital, Southern Medical University
Beijing 302 Hospital
Beijing Ditan Hospital
Shenzhen Third People's 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
1. Voluntarily signed informed consent form 2. Aged 18-65 years 3. Traditional Chinese Medicine (TCM) syndrome type of Shi-re-du-yun 4. Meeting the diagnostic criteria for hepatitis B-related cirrhosis 5. aMAP score \> 60
Exclusion criteria
1. Previously diagnosed with or treated for hepatocellular carcinoma (HCC) or other malignancies 2. Pregnant or lactating women 3. Decompensated cirrhosis (e.g., presence of obvious ascites, hepatic encephalopathy, or gastrointestinal bleeding) 4. 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 5. Severe cardiac, renal, respiratory, or hematopoietic system diseases 6. Determined by the investigator to be unsuitable for participation in this trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hepatocellular carcinoma incidence in high-risk patients with hepatitis B-related cirrhosis during a 96-week follow-up | From enrollment to the end of treatment at 96 weeks |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Contacts
CONTACTRong Fan
Outcome results
None listed