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Hospital-Based Management of Patients With Chronic Hepatitis B Virus Infection

StatusRecruiting
PhaseNot specified
Started
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Record History

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  1. Notable Primary completion date: Jan 15, 2026 to Jun 30, 2027v2 Show 10 more changesShow less
    • Primary endpoints: 1 to 2
    • Trial status: Enrolling by Invitation to Recruiting
    • Enrollment target: 16000 to 16300
    • Study completion date: Jan 15, 2026 to Dec 31, 2027
    • Interventions: Facilitate the referral of in-hospital chronic hepatitis B patients and provide treatment and follow-up in the infectious disease… to Assessment of patient-reported outcomes (PROs) in patients with chronic hepatitis B. (Other), Facilitate the referral of in-hospital…
    • Eligibility criteria expanded, about 140 words
    • Secondary endpoints: 2 to 4
    • Study description expanded, about 117 words
    • Site details revised at 3 of 3 sites
    • Study arms: 1 to 2
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Since 2022, the Third Affiliated Hospital of Sun Yat-sen University has initiated the "Hot Wave Project", a comprehensive hepatitis B infection prevention and management system encompassing patient education, screening, referral, treatment, and follow-up. In 2024, this system was expanded to the Sixth Affiliated Hospital and the Fifth Affiliated Hospital of Sun Yat-sen University, transitioning into a multicenter, hospital-based cohort study on hepatitis B management.The primary objective of this study is to increase the referral rate of HBsAg-positive patients in non-hepatology/non-infectious disease departments to 50%. The secondary objective is to improve the treatment rate of hepatitis B infected patients in non-hepatology/non-infectious disease departments, particularly focusing on the diagnosed but untreated (DBU) population. Furthermore, this study aims to analyze the cost-effectiveness and clinical benefits of in-hospital hepatitis B screening and management strategies.In 2025, a Patient-Reported Outcomes (PRO) sub-study was added to the project to evaluate the impact of antiviral therapy on the Health-Related Quality of Life among a cohort of treatment-naïve patients with chronic hepatitis B.
Trial Details
NCT Number NCT06966908
Lead Sponsor Third Affiliated Hospital, Sun Yat-Sen University
Conditions
(from sponsor)
Chronic Hepatitis B
Related terms Hepatitis B, Chronic
Enrollment 16,300 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov