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

Sponsor
Nanfang Hospital, Southern Medical University
Study ID
NCT07544121
Status
Not Yet Recruiting

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Conditions

  • Cirrhosis, Liver
  • HEPATITIS B CHRONIC
  • Hepatocellular Carcinoma (HCC)

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

First listed
Apr 22, 2026
Start date
Apr 1, 2026
Status verified
Apr 2026
Primary completion
Apr 1, 2028
Completion
Nov 30, 2028

Study Design

Enrollment
1,034 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Experimental: Standard antiviral therapy + Babao Dan Capsule
    receive Babao Dan Capsule (0.6 g per dose, three times daily) in addition to standard antiviral therapy.
  • Placebo Comparator: Placebo Comparator: Standard antiviral therapy + Placebo
    receive Babao Dan Capsule simulant (0.6 g per dose, three times daily) in addition to standard antiviral therapy.

Primary Outcome Measure

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 ]

Central Contacts

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