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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

ConditionsCirrhosis, LiverHepatocellular Carcinoma (HCC)HEPATITIS B CHRONIC
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorNanfang Hospital, Southern Medical University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Voluntarily signed informed consent form

Aged 18-65 years

Traditional Chinese Medicine (TCM) syndrome type: Qi-zhi -xue-yu

Meeting the diagnostic criteria for hepatitis B-related cirrhosis

Disqualifiers

[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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

1,034 Participants
are divided into 2 treatment groups
Group A: Experimental: Standard antiviral therapy + Biejia-Ruangan compoundExperimental treatment 1 intervention
Group B: Placebo Comparator: Standard antiviral therapy + PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of HCC confirmed by imaging or histology at Week 96 of follow-up

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

Secondary outcomes

1

Non-HCC liver-related events and other the clinical changes or incidence rates

1. Liver-related death; 2. Incidence of non-HCC events and non-liver-related death; 3. Changes in liver function, liver fibrosis degree, and tumor markers; 4. Trends in the four diagnostic methods of traditional Chinese medicine and changes in TCM syndrome scores; 5. Incidence of adverse events (AEs) and serious adverse events (SAEs).

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Nanfang Hospital, Southern Medical University

Lead sponsor

Shenzhen Third People's Hospital

Collaborator

Beijing Ditan Hospital

Collaborator

Beijing 302 Hospital

Collaborator

Source ClinicalTrials.gov

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