NCT07520123

Brief Summary

The World Health Organization (WHO) has set a target to eliminate viral hepatitis by 2030, aiming for a 90% diagnosis rate and an 80% treatment rate for chronic hepatitis B (CHB). However, as of 2024, only 26.1% of CHB infections globally have been diagnosed, and only 14.6% have received treatment, with treatment coverage falling far short of the target. A large number of patients are in a "Diagnosed-but-Untreated (DBU)" state, with major barriers including: low disease awareness, concerns about medication side effects, fragmented healthcare pathways, and poor physician-patient communication. Traditional hospital-based follow-up models are constrained by human resources and the capacity for health information system integration, making them difficult to scale widely in primary care settings. Supported by the National Key R\&D Program of China, our team has successfully developed the world's first infectious disease agent (Union-Agent) after more than two years of research. This study aims to conduct a multicenter, prospective, two-cohort observational and interventional investigation to identify the reasons why DBU patients fail to initiate treatment and to explore whether an intervention using the Union-Agent can significantly increase the rate of antiviral treatment initiation within six months among DBU patients who meet the antiviral indications according to the 2022 Chinese guidelines for the prevention and treatment of chronic hepatitis B. The study hypothesizes that, compared to baseline, the Union-Agent can enable 50%-60% of treatment-eligible DBU patients to initiate antiviral therapy within six months.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
2,000

participants targeted

Target at P75+ for not_applicable

Timeline
18mo left

Started May 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress7%
May 2026Dec 2027

First Submitted

Initial submission to the registry

February 28, 2026

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 9, 2026

Completed
22 days until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2027

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

April 9, 2026

Status Verified

February 1, 2026

Enrollment Period

1.5 years

First QC Date

February 28, 2026

Last Update Submit

April 6, 2026

Conditions

Chronic Hepatitis B

Keywords

Agent Intelligencechronic hepatitis Bhepatitis B virusdiagnosed-but-untreated

Outcome Measures

Primary Outcomes (1)

  • Proportion of DBU patients initiating antiviral treatment

    6-month antiviral treatment initiation rate in DBU patients meeting 2022 Chinese CHB guideline indications: * Absolute increase: ≥10 percentage points from baseline. * Relative increase: 50% from baseline.

    from enrollment to six months post-enrollment

Secondary Outcomes (4)

  • Multilevel Barriers to Antiviral Treatment in DBU CHB Patients

    From baseline assessment until 6 months of intervention, assessed at baseline and 6 months of intervention via Union-Agent's built-in structured questionnaire and clinical record review.

  • Proportion of DBU Patients with Correct Recognition of Core HBV Knowledge

    From baseline assessment until 6 months of intervention, assessed at baseline and 6 months of intervention using the Union-Agent HBV Knowledge Assessment Scale.

  • Change in Average Review Intervals in DBU Patients with Irregular Follow-Up History

    From the start of Union-Agent intervention until 6 months of intervention, assessed up to 6 months via Union-Agent follow-up logs to determine changes in average review intervals.

  • Proportion of Real-Time High-Risk Event Detection in DBU Patients

    From the start of Union-Agent intervention until 6 months of intervention, assessed up to 6 months via the Union-Agent risk stratification module to detect high-risk events in real time.

Study Arms (1)

patients diagnosed with Chronic Hepatitis B but Untreated

EXPERIMENTAL

A multicenter, prospective, dual-cohort (observational + interventional) study with a self-controlled baseline design. The study includes two core phases: 1. Baseline cross-sectional survey: Characterize DBU patients, identify treatment barriers, and establish stratification variables for intervention. 2. Prospective interventional cohort: Patients receive routine care plus four Union-Agent-driven services, with real-time data collection to evaluate treatment uptake and clinical outcomes. Core Services for Patients * Guideline-based personalized education; * Standardized treatment recommendations; ③ Individualized medication reminders; ④ Semantic follow-up and risk assessment; ⑤ Automated scheduling: Reminders for routine reviews, lab tests, and appointment booking; support for uploading lab results for physician review.

Other: Agent Intelligence education

Interventions

Agent Intelligence educationOTHER

Patients, while receiving usual care, will also receive four services from Union-Agent: (i) guideline-based educational modules tailored to patients' baseline knowledge of hepatitis B; (ii) personalized medication reminders with real-time adherence records; (iii) semantic follow-up that converts patient-reported symptoms into structured data and generates early risk alerts; and (iv) algorithm-driven referral suggestions aligned with China's three-tiered healthcare referral system.

Also known as: Agent Intelligence, education, antiviral treatment
patients diagnosed with Chronic Hepatitis B but Untreated

Eligibility Criteria

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

You may qualify if:

  • Aged ≥18 years with persistent HBsAg positivity for ≥6 months (diagnosed as chronic hepatitis B \[CHB\] per the latest Chinese Guidelines for the Prevention and Treatment of Chronic Hepatitis B).
  • Treatment-naïve to nucleos(t)ide analogues (NUCs), or previous NUC treatment with no medication for the past 6 months (diagnosed-but-untreated \[DBU\] status).
  • Capable of using a smartphone independently or with family member assistance.
  • Voluntarily provides written informed consent (electronic version) and agrees to study procedures and follow-up.

You may not qualify if:

  • Severe mental or cognitive impairment that impairs study cooperation.
  • Current participation in other interventional clinical trials that may influence HBV treatment decisions.
  • Inability to use a smartphone even with assistance.
  • Refusal to sign the informed consent form.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Infectious Disease, Wuhan Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430022, China

Location

Related Publications (6)

  • Romero-Vico J, Feliu A, Vargas-Accarino E, Sanchez-Gavilan E, Ribo M, Palom A, Ruiz-Cobo JC, Riveiro M, Fabrellas N, Buti M. Enhancing Chronic Hepatitis B and D Management Through a Tailored Mobile Health Application: Real-World Outcomes From the Adaptation of the NORA App. J Viral Hepat. 2026 Apr;33(4):e70160. doi: 10.1111/jvh.70160.

    PMID: 41731678RESULT

  • Du Y, Zheng Y, Wang H, Zheng X. The epidemiological characteristics of patients with chronic hepatitis B: a single-center retrospective study. APASL 2025, Beijing (PP0154); 2025.

    RESULT

  • World Health Organization. Global hepatitis report 2024: action for access in low- and middle-income countries. Geneva: WHO; 2024.

    RESULT

  • World Health Organization. Global health sector strategy on viral hepatitis 2016-2021: Towards ending viral hepatitis. Geneva: WHO; 2016.

    RESULT

  • Deng Q, Wu S, Liu W. Effect of social influence on antiviral therapy behavior among chronic hepatitis B patients with different disease knowledge levels. BMC Public Health. 2025 Apr 17;25(1):1441. doi: 10.1186/s12889-025-22683-7.

    PMID: 40247234RESULT

  • Yan R, Sun M, Yang H, Du S, Sun L, Mao Y. 2024 latest report on hepatitis B virus epidemiology in China: current status, changing trajectory, and challenges. Hepatobiliary Surg Nutr. 2025 Feb 1;14(1):66-77. doi: 10.21037/hbsn-2024-754. Epub 2025 Jan 17.

    PMID: 39925891RESULT

MeSH Terms

Conditions

Hepatitis B, ChronicHepatitis B

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Central Study Contacts

Xin Zheng, Doctor of Philosophy

CONTACT

+86 18602724981xinz@hust.edu.cn

Yanqin Du, Doctor of Medicine

CONTACT

+86 15871741706yanqindu@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 28, 2026

First Posted

April 9, 2026

Study Start

May 1, 2026

Primary Completion (Estimated)

November 1, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

April 9, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)