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

Sponsor
Nanfang Hospital, Southern Medical University
Study ID
NCT07481032
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

  • Biejia-Ruangan compound — DRUG
    receive Biejia-Ruangan compound (2.0 g per dose, three times daily) in addition to standard antiviral therapy
  • Biejia-Ruangan compound simulant — DRUG
    receive Biejia-ruangan compound simulant (2.0 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 Qi-zhi-xue\_yu syndrome and have an aMAP score \>60 points. The objective is to evaluate whether combining Bie-jia-ruan-gan with standard anti-hepatitis B virus therapy can further reduce the incidence of HCC in this high-risk population.

Key Dates

First listed
Mar 18, 2026
Start date
Apr 1, 2026
Status verified
Mar 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 + Biejia-Ruangan compound
    receive Biejia-Ruangan compound (2.0 g per dose, three times daily) in addition to standard antiviral therapy.
  • Placebo Comparator: Placebo Comparator: Standard antiviral therapy + Placebo
    receive Bie-jia-ruan-gan simulant (2.0 g per dose, three times daily) in addition to standard antiviral therapy

Primary Outcome Measure

Incidence of HCC confirmed by imaging or histology at Week 96 of follow-up [ Time Frame: From enrollment to the end of treatment at 96 weeks ]

Central Contacts

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