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Recruiting NCT07169656

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

Trial Parameters

Condition Chronic Hepatitis b
Sponsor The First Affiliated Hospital of Zhengzhou University
Study Type OBSERVATIONAL
Phase N/A
Enrollment 15,000
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2024-06-03
Completion 2032-06-30
Interventions
ETV,TDF,TAF,TMFPeginterferon α-2b injection

Brief Summary

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.

Eligibility Criteria

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).

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