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NCT Number: NCT07544121

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

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.

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Key information

Conditions

HEPATITIS B CHRONIC Adenocarcinoma Blood-Borne Infections Carcinoma Carcinoma, Hepatocellular Chronic Disease Cirrhosis, Liver Communicable Diseases DNA Virus Infections Digestive System Diseases Digestive System Neoplasms Disease Attributes Fibrosis Hepadnaviridae Infections Hepatitis Hepatitis B Hepatitis B, Chronic Hepatitis, Chronic Hepatitis, Viral, Human Hepatocellular Carcinoma (HCC) Infections Liver Cirrhosis Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Pathologic Processes Pathological Conditions, Signs and Symptoms Virus Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Babao Dan Capsule

Drug

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

Babao Dan Capsule simulant

Drug

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

Primary outcomes

  1. 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 outcomes

  1. Incidence of hepatic decompensation events

    Time frame: From enrollment to the end of treatment at 96 weeks

  2. Trends in the four diagnostic methods of traditional Chinese medicine

    Time frame: From enrollment to the end of treatment at 96 weeks

  3. Incidence of adverse events (AEs)

    Time frame: From enrollment to the end of treatment at 96 weeks

  4. Incidence of serious adverse events (SAEs).

    Time frame: From enrollment to the end of treatment at 96 weeks

  5. FIB-4 index

    Time frame: From enrollment to the end of treatment at 96 weeks

  6. aspartate aminotransferase (AST)

    Time frame: From enrollment to the end of treatment at 96 weeks

  7. alanine aminotransferase (ALT)

    Time frame: From enrollment to the end of treatment at 96 weeks

  8. alpha-fetoprotein (AFP)

    Time frame: From enrollment to the end of treatment at 96 weeks

Study contacts

Contact information is provided by the study sponsor or research team.

Rong Fan

CONTACT

[email protected]

020-62786534

Sponsors and collaborators

Lead sponsor

Nanfang Hospital, Southern Medical University

Other

Collaborators

  • Beijing 302 Hospital
  • Beijing Ditan Hospital
  • Shenzhen Third People's Hospital

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Apr 22, 2026
Registry last updated
Apr 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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