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Not yet recruiting NCT07544121

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

No phase Interventional HEPATITIS B CHRONIC Cirrhosis, Liver Hepatocellular Carcinoma (HCC)

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: Babao Dan Capsule, Babao Dan Capsule simulant.
Who it may be relevant to
Registry conditions: HEPATITIS B CHRONIC, Cirrhosis, Liver, Hepatocellular Carcinoma (HCC). 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 →

Official title

Effect of Babao Dan Capsule Combined With Antiviral Therapy on the Incidence of Hepatocellular Carcinoma in Patients With Hepatitis B-related Cirrhosis: A Multicenter, Randomized, Placebo-controlled Study

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.

Interventions

  • Drug Babao Dan Capsule
    receive compound Babao Dan Capsule (0.6 g per dose, three times daily) in addition to standard antiviral therapy.
  • Drug Babao Dan Capsule simulant
    receive compound Babao Dan Capsule simulant (0.6 g per dose, three times daily) in addition to standard antiviral therapy.

Primary outcome measures

  • Hepatocellular carcinoma incidence in high-risk patients with hepatitis B-related cirrhosis during a 96-week follow-up [Time frame: From enrollment to the end of treatment at 96 weeks]
Secondary outcome measures (8)
  • Incidence of hepatic decompensation events [Time frame: From enrollment to the end of treatment at 96 weeks]
  • Trends in the four diagnostic methods of traditional Chinese medicine [Time frame: From enrollment to the end of treatment at 96 weeks]
  • Incidence of adverse events (AEs) [Time frame: From enrollment to the end of treatment at 96 weeks]
  • Incidence of serious adverse events (SAEs). [Time frame: From enrollment to the end of treatment at 96 weeks]
  • FIB-4 index [Time frame: From enrollment to the end of treatment at 96 weeks]
  • aspartate aminotransferase (AST) [Time frame: From enrollment to the end of treatment at 96 weeks]
  • alanine aminotransferase (ALT) [Time frame: From enrollment to the end of treatment at 96 weeks]
  • alpha-fetoprotein (AFP) [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 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
  • 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: NCT07544121 · NFEC-2026-138

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗