MedTrace Logo

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

NCT07481032 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1034

Last updated 2026-03-18

No results posted yet for this study

Summary

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.

Conditions

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

Interventions

DRUG

Biejia-Ruangan compound

receive Biejia-Ruangan compound (2.0 g per dose, three times daily) in addition to standard antiviral therapy

DRUG

Biejia-Ruangan compound simulant

receive Biejia-ruangan compound simulant (2.0 g per dose, three times daily) in addition to standard antiviral therapy

Sponsors & Collaborators

  • Shenzhen Third People's Hospital

    collaborator OTHER

  • Beijing Ditan Hospital

    collaborator OTHER

  • Beijing 302 Hospital

    collaborator OTHER

  • Nanfang Hospital, Southern Medical University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-01
Primary Completion
2028-04-01
Completion
2028-11-30

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07481032 on ClinicalTrials.gov