NCT07544121

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 Shi-re-du-yun syndrome and have an aMAP score \>60 points. The objective is to evaluate whether combining Babao Dan Capsule with standard anti-hepatitis B virus therapy can further reduce the incidence of HCC in this high-risk population.

Trial Health

65
Monitor

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
31mo 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 Progress4%
Apr 2026Nov 2028

First Submitted

Initial submission to the registry

March 15, 2026

Completed
17 days until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
21 days until next milestone

First Posted

Study publicly available on registry

April 22, 2026

Completed
1.9 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

April 22, 2026

Status Verified

April 1, 2026

Enrollment Period

2 years

First QC Date

March 15, 2026

Last Update Submit

April 19, 2026

Conditions

HEPATITIS B CHRONICCirrhosis, LiverHepatocellular Carcinoma (HCC)

Outcome Measures

Primary Outcomes (1)

  • Hepatocellular carcinoma incidence in high-risk patients with hepatitis B-related cirrhosis during a 96-week follow-up

    From enrollment to the end of treatment at 96 weeks

Secondary Outcomes (8)

  • Incidence of hepatic decompensation events

    From enrollment to the end of treatment at 96 weeks

  • Trends in the four diagnostic methods of traditional Chinese medicine

    From enrollment to the end of treatment at 96 weeks

  • Incidence of adverse events (AEs)

    From enrollment to the end of treatment at 96 weeks

  • Incidence of serious adverse events (SAEs).

    From enrollment to the end of treatment at 96 weeks

  • FIB-4 index

    From enrollment to the end of treatment at 96 weeks

  • +3 more secondary outcomes

Study Arms (2)

Experimental: Standard antiviral therapy + Babao Dan Capsule

EXPERIMENTAL

receive Babao Dan Capsule (0.6 g per dose, three times daily) in addition to standard antiviral therapy.

Drug: Babao Dan Capsule

Placebo Comparator: Standard antiviral therapy + Placebo

PLACEBO COMPARATOR

receive Babao Dan Capsule simulant (0.6 g per dose, three times daily) in addition to standard antiviral therapy.

Drug: Babao Dan Capsule simulant

Interventions

Babao Dan CapsuleDRUG

receive compound Babao Dan Capsule (0.6 g per dose, three times daily) in addition to standard antiviral therapy.

Experimental: Standard antiviral therapy + Babao Dan Capsule
Babao Dan Capsule simulantDRUG

receive compound Babao Dan Capsule simulant (0.6 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 of Shi-re-du-yun
  • 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

Hepatitis B, ChronicLiver CirrhosisCarcinoma, Hepatocellular

Interventions

babao dan

Condition Hierarchy (Ancestors)

Hepatitis BBlood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsFibrosisAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by Site

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

April 22, 2026

Study Start

April 1, 2026

Primary Completion (Estimated)

April 1, 2028

Study Completion (Estimated)

November 30, 2028

Last Updated

April 22, 2026

Record last verified: 2026-04