NCT07481032

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,034 (estimated)
• Sponsor: Nanfang Hospital, Southern Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2026-04-01
• Primary completion: 2028-04-01
• Completion: 2028-11-30
• First posted: 2026-03-18
• Last updated: 2026-03-18