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Recruiting

NCT Number: NCT07169656

Observation Study on Reducing the Risk of Liver Cancer Associated With Hepatitis B (Zhiyuan) Project.

This study is a multicenter, prospective, observational real-world study designed to investigate and analyze the current treatment patterns of chronic hepatitis B (CHB) across 200 hospitals in China. By comparing patient outcomes under different therapeutic regimens, it aims to provide high-quality evidence-based medical data to optimize CHB treatment strategies and follow-up protocols, ultimately contributing to the advancement of a functional cure for chronic hepatitis B.

Recruiting

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Key information

Conditions

Chronic Hepatitis B Blood-Borne Infections Chronic Disease Communicable Diseases DNA Virus Infections Digestive System Diseases Disease Attributes Hepadnaviridae Infections Hepatitis Hepatitis B Hepatitis B, Chronic Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Huaxian People's Hospital, Anyang, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 1.Chronic HBV infection (HBsAg-positive for ≥6 months); 2.Age ≥18 years; 3.Patients who, based on real-world clinical practice needs, are planned or currently receiving treatment with:Entecavir (ETV),Tenofovir disoproxil fumarate (TDF),Tenofovir alafenamide fumarate (TAF),Tenofovir amibufenamide (TMF) OR Pegylated interferon α-2b-naïve patients OR Patients re-initiating pegylated interferon α-2b therapy; 4.Written informed consent obtained from the patient.

Exclusion criteria

  • 1.Severe hepatic dysfunction or decompensated cirrhosis; 2.Concurrent participation in other clinical trials; 3.Hepatocellular carcinoma (HCC).

Treatment and study plan

ETV,TDF,TAF,TMF

Drug

treated with entecavir (ETV), tenofovir disoproxil fumarate (TDF), tenofovir alafenamide fumarate (TAF), or tenofovir amibufenamide (TMF)

Peginterferon α-2b injection

Drug

treated with Peginterferon α-2b injection

Primary outcomes

  1. Percentage of patients with HBsAg-associated HCC post-therapy

    Time frame: Week 4-240

  2. Hepatocellular Carcinoma (HCC) Incidence

    Time frame: Week 4-240

Secondary outcomes

  1. Number of chronic hepatitis B (CHB) patients with accurate knowledge/awareness of HBV

    Time frame: Week 4-240

  2. Rate of HBsAg seroclearance

    Time frame: Week 4-240

  3. HBsAg seroconversion rate

    Time frame: Week 4-240

  4. Number of patients with altered HBsAg levels post-treatment

    Time frame: Week 4-240

  5. Number of patients with HBsAg level decline from baseline

    Time frame: Week 4-240

  6. HBeAg seroconversion rate

    Time frame: Week 4-240

  7. HBV DNA

    Time frame: Week 4-240

  8. Liver fibrosis improvement rate

    Time frame: Week 4-240

  9. Incidence of liver cirrhosis

    Time frame: Week 4-240

  10. Incidence of decompensated cirrhosis

    Time frame: Week 4-240

  11. Incidence of decompensation-related complications

    Time frame: Week 4-240

  12. Liver transplantation incidence rate

    Time frame: Week 4-240

  13. Post-treatment relapse rate

    Time frame: Week 4-240

Study contacts

Contact information is provided by the study sponsor or research team.

Hongxia Liang

CONTACT

[email protected]

18595871806

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital of Zhengzhou University

Other

Registry information

Important dates

Study start
2024
Primary completion
2032
Study completion
2032
First posted
Sep 12, 2025
Registry last updated
Sep 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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