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

NCT07169656 · tracked via the Priya Life Science China tracker

Sponsor

The First Affiliated Hospital of Zhengzhou University

Phase

Observational

Started

2024-06-03

Last updated

2025-09-12

Condition(s) studied

Chronic Hepatitis b

Investigational drug(s) / intervention(s)

ETV,TDF,TAF,TMFPeginterferon α-2b injection →

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

Peginterferon α-2b injection: treated with Peginterferon α-2b injection

Study 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

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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).

Primary outcome measure(s)

Percentage of patients with HBsAg-associated HCC post-therapy — Week 4-240
Hepatocellular Carcinoma (HCC) Incidence — Week 4-240

Trial sites (162)

Facility	City	Region	Status
Huaxian People's Hospital	Anyang	China	Recruiting
Linzhou City People's Hospital	Anyang	China	Recruiting
Neihuang County People's Hospital	Anyang	China	Recruiting
Tangyin County People's Hospital	Anyang	China	Recruiting
The Fifth People's Hospital of Anyang	Anyang	China	Recruiting
The First Affiliated Hospital of Xinxiang Medical University (Hua County Branch)	Anyang	China	Recruiting
Guangzhou First People's Hospital	Guangzhou	China	Recruiting
The First Affiliated Hospital of Jinan University (Guangzhou Overseas Chinese Hospital)	Guangzhou	China	Recruiting
Hebi Coal Mining Group General Hospital	Hebi	China	Recruiting
Hebi Infectious Disease Hospital	Hebi	China	Recruiting
Junxian County People's Hospital	Hebi	China	Recruiting
Bo'ai County People's Hospital	Jiaozuo	China	Recruiting
Mengzhou Hospital of Traditional Chinese Medicine	Jiaozuo	China	Recruiting
Qinyang People's Hospital	Jiaozuo	China	Recruiting
The Secend People's Hospital of Jiaozuo	Jiaozuo	China	Recruiting
The Third People's Hospital of Jiaozuo	Jiaozuo	China	Recruiting
Xiuwu People's Hospital	Jiaozuo	China	Recruiting
Wenxian People's Hospital	Jiayuguan	China	Recruiting
Jiyang County Hospital of Traditional Chinese Medicine	Jinan	China	Recruiting
Shandong Public Health Clinical Center	Jinan	China	Recruiting
Jiyuan People's Hospital	Jiyuan	China	Recruiting
Jiyuan Traditional Chinese Medicine Hospital	Jiyuan	China	Recruiting
Huaihe Hospital of Henan University	Kaifeng	China	Recruiting
Infectious Diseases Hospital of Kaifeng	Kaifeng	China	Recruiting
Kaifeng Central Hospital	Kaifeng	China	Recruiting
Kaifeng Hospital of Traditional Chinese Medicine	Kaifeng	China	Recruiting
Lankao First Hospital Group	Kaifeng	China	Recruiting
Qixian People's Hospital	Kaifeng	China	Recruiting
The People's Hospital of Weishi	Kaifeng	China	Recruiting
Tongxu County People's Hospital	Kaifeng	China	Recruiting
Weishi County People's Hospital	Kaifeng	China	Recruiting
Linyi Hospital of Traditional Chinese Medicine	Linyi	China	Recruiting
Linyi People's Hospital	Linyi	China	Recruiting
Linying County People's Hospital	Luohe	China	Recruiting
Luohe Central Hospital	Luohe	China	Recruiting
Luanchuan County People's Hospital	Luoyang	China	Recruiting
Luoning County People's Hospital	Luoyang	China	Recruiting
Luoyang Central Hospital	Luoyang	China	Recruiting
Luoyang First People's Hospital	Luoyang	China	Recruiting
Luoyang Third People's Hospital	Luoyang	China	Recruiting

+ 122 more sites — see the full list on the official registry below.

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Other trials for the same condition

The Effectiveness and Safety of TMF in the Treatment of Chronic Hepatitis B Patients With Normal ALT. Active, not recruiting

A Clinical Study Evaluating the Pharmacokinetic Characteristics and Safety of AHB-137 Injection in Participants With Mild to Moderate Liver Dysfunction and Those With Normal Liver Function. Recruiting

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

A Study to Evaluate the Antiviral Activity and Immune Response of AHB-137 Injection in Participants With Chronic Hepatitis B (CHB) Active, not recruiting

A Follow-up Study of Peginterferon Alfa-2b Combined With TDF in Patients With Chronic Hepatitis B Enrolling by invitation

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07169656 on ClinicalTrials.gov ↗ ← All trials in China