Reducing liver cancer risk in people with chronic hepatitis B — Zhiyuan Project
Official title: Observation Study on Reducing the Risk of Liver Cancer Associated With Hepatitis B (Zhiyuan) Project.
Run by The First Affiliated Hospital of Zhengzhou University · NCT07169656 · Data updated 2026-11-12
This project will follow adults with chronic hepatitis B who are receiving common antiviral or pegylated interferon treatments to see if different therapies affect liver cancer risk and other long-term outcomes.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 15000 (estimated) |
| Sponsor | The First Affiliated Hospital of Zhengzhou University Academic / other |
| Locations | 162 sites (Anyang and 161 other locations) |
| Status | Recruiting |
| Started | June 3, 2024 |
| Main results expected | June 30, 2032 |
| Study ends | December 31, 2032 |
| Registry record updated | September 12, 2025 |
| Trial ID | NCT07169656 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18 years) with chronic HBV infection (HBsAg positive for ≥6 months) who are planned or currently treated with entecavir, TDF, TAF, TMF, or pegylated interferon α-2b and can provide informed consent are ideal candidates.
✕Probably not a fit
Patients with severe hepatic dysfunction or decompensated cirrhosis, existing hepatocellular carcinoma, or those enrolled in other interventional trials are unlikely to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a multicenter, prospective, observational real-world study collecting treatment and outcome data from adults with chronic hepatitis B across hospitals in China. Participants receiving commonly used antivirals (entecavir, TDF, TAF, TMF) or pegylated interferon α-2b will be followed under usual-care conditions to compare outcomes such as viral suppression, liver function, hepatocellular carcinoma development, and markers related to functional cure. Patients with decompensated cirrhosis, existing hepatocellular carcinoma, or concurrent participation in other interventional trials are excluded, and written informed consent is required. The study aims to analyze real-world treatment patterns and long-term outcomes to inform optimized treatment and follow-up strategies.
Why it matters
Potential benefit: If successful, the study could identify which commonly used therapies are linked to lower liver cancer risk and better long-term outcomes, helping clinicians personalize treatment and monitoring.
How similar studies have gone: Previous randomized trials and observational cohorts have shown that nucleos(t)ide analogs and pegylated interferon can reduce disease progression and HCC risk, but comprehensive real-world comparisons across many hospitals are less common.
Who can join: the full rules
Show full inclusion / exclusion 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).
Where it's running
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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
Show 44 more locations
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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 -
Ruyang County People's Hospital
Luoyang, China Recruiting -
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, China Recruiting -
Xin'an County People's Hospital
Luoyang, China Recruiting -
Yichuan County Hospital of Traditional Chinese Medicine
Luoyang, China Recruiting -
Yiyang County People's Hospital
Luoyang, China Recruiting -
Dengzhou Central Hospital
Nanyang, China Recruiting -
Dengzhou People's Hospital
Nanyang, China Recruiting -
Fangcheng County People's Hospital
Nanyang, China Recruiting -
Nanyang Central Hospital
Nanyang, China Recruiting -
Nanyang First People's Hospital
Nanyang, China Recruiting
+112 more sites. See ClinicalTrials.gov for the full list.
Study contacts
- Principal investigator: Hongxia Liang — The First Affiliated Hospital of Zhengzhou University
- Study coordinator: Hongxia Liang
- Email: hxliang@zzu.edu.cn
- Phone: 18595871806
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Impact of functional cure on patient-reported outcomes in chronic hepatitis B
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Sequential combination therapy for functional cure of chronic hepatitis B
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-
Combination therapy for functional cure in chronic hepatitis B
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-
GST-HG131/GST-HG141 tablets vs placebo in chronic hepatitis B
A phase IIa trial tests GST-HG131 and GST-HG141 tablets against placebo to see if they are safe and help people with chronic hepatitis B.
-
AHB-137 injection in people with chronic hepatitis B
This study tests AHB-137 vs placebo in adults with chronic hepatitis B who have not yet received antiviral treatment.
-
AHB-137 injection pharmacokinetics and safety in people with mild to moderate liver dysfunction and normal liver function
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.