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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorThe First Affiliated Hospital of Zhengzhou University

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial population

Patients were selected from chronic hepatitis B (CHB) cases across 200 national hospitals

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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

Treatment groups

15,000 Participants
are divided into 2 treatment groups
Group A: Group 11 intervention
Group B: Group 21 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

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