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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Biejia-Ruangan compound, Biejia-Ruangan compound simulant.
- Who it may be relevant to
- Registry conditions: Cirrhosis, Liver, Hepatocellular Carcinoma (HCC), HEPATITIS B CHRONIC. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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
- Drug Biejia-Ruangan compound
receive Biejia-Ruangan compound (2.0 g per dose, three times daily) in addition to standard antiviral therapy - Drug Biejia-Ruangan compound simulant
receive Biejia-ruangan compound simulant (2.0 g per dose, three times daily) in addition to standard antiviral therapy
Primary outcome measures
- Incidence of HCC confirmed by imaging or histology at Week 96 of follow-up [Time frame: From enrollment to the end of treatment at 96 weeks]
Secondary outcome measures (1)
- Non-HCC liver-related events and other the clinical changes or incidence rates [Time frame: From enrollment to the end of treatment at 96 weeks]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Prevention
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07481032 · NFEC-2026-139