Effect of Babao Dan Capsule Combined With Antiviral Therapy on the Incidence of Hepatocellular Ca… (NCT07544121) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Effect of Babao Dan Capsule Combined With Antiviral Therapy on the Incidence of Hepatocellular Carcinoma in Patients With Hepatitis B-related Cirrhosis
1,034 participantsStarted 2026-04-01
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. 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
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
What they're measuring
1
Hepatocellular carcinoma incidence in high-risk patients with hepatitis B-related cirrhosis during a 96-week follow-up
Timeframe: From enrollment to the end of treatment at 96 weeks
Trial details
NCT IDNCT07544121
SponsorNanfang Hospital, Southern Medical University