NCT07481032

Brief 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.

Trial Health

65
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,034

participants targeted

Target at P75+ for not_applicable

Timeline
29mo left

Started Apr 2026

Typical duration for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress8%
Apr 2026Nov 2028

First Submitted

Initial submission to the registry

March 15, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 18, 2026

Completed
14 days until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2028

Expected
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2028

Last Updated

March 18, 2026

Status Verified

March 1, 2026

Enrollment Period

2 years

First QC Date

March 15, 2026

Last Update Submit

March 15, 2026

Conditions

Cirrhosis, LiverHepatocellular Carcinoma (HCC)HEPATITIS B CHRONIC

Outcome Measures

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

    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

    From enrollment to the end of treatment at 96 weeks

Study Arms (2)

Experimental: Standard antiviral therapy + Biejia-Ruangan compound

EXPERIMENTAL

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

Drug: Biejia-Ruangan compound

Placebo Comparator: Standard antiviral therapy + Placebo

PLACEBO COMPARATOR

receive Bie-jia-ruan-gan simulant (2.0 g per dose, three times daily) in addition to standard antiviral therapy

Drug: Biejia-Ruangan compound simulant

Interventions

Biejia-Ruangan compoundDRUG

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

Experimental: Standard antiviral therapy + Biejia-Ruangan compound
Biejia-Ruangan compound simulantDRUG

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

Placebo Comparator: Standard antiviral therapy + Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • aMAP score \> 60

You may not qualify if:

  • \[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
  • Severe cardiac, renal, respiratory, or hematopoietic system diseases
  • Determined by the investigator to be unsuitable for participation in this trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Liver CirrhosisCarcinoma, HepatocellularHepatitis B, Chronic

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and SymptomsAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteHepatitis BBlood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitis, ChronicHepatitisChronic DiseaseDisease Attributes

Central Study Contacts

Rong Fan

CONTACT

020-62786534rongfansmu@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 15, 2026

First Posted

March 18, 2026

Study Start

April 1, 2026

Primary Completion (Estimated)

April 1, 2028

Study Completion (Estimated)

November 30, 2028

Last Updated

March 18, 2026

Record last verified: 2026-03