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
Starting soon · Not applicable · Has a placebo group
Conditions studied: Cirrhosis, Liver, Hepatocellular Carcinoma (HCC), HEPATITIS B CHRONIC
In brief
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.
Key facts
- Study ID
- NCT07481032
- Run by
- Nanfang Hospital, Southern Medical University
- People needed
- 1034
- Starts
- 2026-04-01
- Expected to finish
- 2028-11-30
- Last updated by the study team
- 2026-03-18
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- [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
Full record on ClinicalTrials.gov
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