Effect of Babao Dan Capsule Combined With Antiviral Therapy on the Incidence of Hepatocellular Carcinoma in Patients With Hepatitis B-related Cirrhosis

N/ANot Yet RecruitingNCT07544121

Nanfang Hospital, Southern Medical University1,034 enrolled

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 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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

1,034

Conditions

HEPATITIS B CHRONIC Cirrhosis, Liver Hepatocellular Carcinoma (HCC)

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Hepatocellular carcinoma incidence in high-risk patients with hepatitis B-related cirrhosis during a 96-week follow-up