Observation Study on Reducing the Risk of Liver Cancer Associated With Hepatitis B (Zhiyuan) Project.
1 other identifier
observational
15,000
1 country
162
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2024
Longer than P75 for all trials
162 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 3, 2024
CompletedFirst Submitted
Initial submission to the registry
June 24, 2025
CompletedFirst Posted
Study publicly available on registry
September 12, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2032
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2032
September 12, 2025
September 1, 2025
8.1 years
June 24, 2025
September 9, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Percentage of patients with HBsAg-associated HCC post-therapy
Week 4-240
Hepatocellular Carcinoma (HCC) Incidence
Week 4-240
Secondary Outcomes (13)
Number of chronic hepatitis B (CHB) patients with accurate knowledge/awareness of HBV
Week 4-240
Rate of HBsAg seroclearance
Week 4-240
HBsAg seroconversion rate
Week 4-240
Number of patients with altered HBsAg levels post-treatment
Week 4-240
Number of patients with HBsAg level decline from baseline
Week 4-240
- +8 more secondary outcomes
Study Arms (2)
Group 1
Group 2
Interventions
treated with entecavir (ETV), tenofovir disoproxil fumarate (TDF), tenofovir alafenamide fumarate (TAF), or tenofovir amibufenamide (TMF)
Eligibility Criteria
Patients were selected from chronic hepatitis B (CHB) cases across 200 national hospitals
You may qualify if:
- 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.
You may not qualify if:
- Severe hepatic dysfunction or decompensated cirrhosis; 2.Concurrent participation in other clinical trials; 3.Hepatocellular carcinoma (HCC).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (162)
Huaxian People's Hospital
Anyang, China
Linzhou City People's Hospital
Anyang, China
Neihuang County People's Hospital
Anyang, China
Tangyin County People's Hospital
Anyang, China
The Fifth People's Hospital of Anyang
Anyang, China
The First Affiliated Hospital of Xinxiang Medical University (Hua County Branch)
Anyang, China
Guangzhou First People's Hospital
Guangzhou, China
The First Affiliated Hospital of Jinan University (Guangzhou Overseas Chinese Hospital)
Guangzhou, China
Hebi Coal Mining Group General Hospital
Hebi, China
Hebi Infectious Disease Hospital
Hebi, China
Junxian County People's Hospital
Hebi, China
Bo'ai County People's Hospital
Jiaozuo, China
Mengzhou Hospital of Traditional Chinese Medicine
Jiaozuo, China
Qinyang People's Hospital
Jiaozuo, China
The Secend People's Hospital of Jiaozuo
Jiaozuo, China
The Third People's Hospital of Jiaozuo
Jiaozuo, China
Xiuwu People's Hospital
Jiaozuo, China
Wenxian People's Hospital
Jiayuguan, China
Jiyang County Hospital of Traditional Chinese Medicine
Jinan, China
Shandong Public Health Clinical Center
Jinan, China
Jiyuan People's Hospital
Jiyuan, China
Jiyuan Traditional Chinese Medicine Hospital
Jiyuan, China
Huaihe Hospital of Henan University
Kaifeng, China
Infectious Diseases Hospital of Kaifeng
Kaifeng, China
Kaifeng Central Hospital
Kaifeng, China
Kaifeng Hospital of Traditional Chinese Medicine
Kaifeng, China
Lankao First Hospital Group
Kaifeng, China
Qixian People's Hospital
Kaifeng, China
The People's Hospital of Weishi
Kaifeng, China
Tongxu County People's Hospital
Kaifeng, China
Weishi County People's Hospital
Kaifeng, China
Linyi Hospital of Traditional Chinese Medicine
Linyi, China
Linyi People's Hospital
Linyi, China
Linying County People's Hospital
Luohe, China
Luohe Central Hospital
Luohe, China
Luanchuan County People's Hospital
Luoyang, China
Luoning County People's Hospital
Luoyang, China
Luoyang Central Hospital
Luoyang, China
Luoyang First People's Hospital
Luoyang, China
Luoyang Third People's Hospital
Luoyang, China
Ruyang County People's Hospital
Luoyang, China
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, China
Xin'an County People's Hospital
Luoyang, China
Yichuan County Hospital of Traditional Chinese Medicine
Luoyang, China
Yiyang County People's Hospital
Luoyang, China
Dengzhou Central Hospital
Nanyang, China
Dengzhou People's Hospital
Nanyang, China
Fangcheng County People's Hospital
Nanyang, China
Nanyang Central Hospital
Nanyang, China
Nanyang First People's Hospital
Nanyang, China
Nanyang Oilfield General Hospital
Nanyang, China
Nanyang Second General Hospital
Nanyang, China
Nanzhao County People's Hospital
Nanyang, China
Neixiang County People's Hospital
Nanyang, China
Sheqi County People's Hospital
Nanyang, China
Tanghe County People's Hospital
Nanyang, China
The First Affiliated Hospital of Nanyang Medical College
Nanyang, China
Xinye County People's Hospital
Nanyang, China
Xixia County People's Hospital
Nanyang, China
Zhenping People's Hospital
Nanyang, China
Ningbo Medical Center Iihuili hospital
Ningbo, China
General Hospital Of Pingmei Shenma Group
Pingdingshan, China
Lushan County People's Hospital
Pingdingshan, China
People's Hospital of Baofeng
Pingdingshan, China
Pingdingshan First People's Hospital
Pingdingshan, China
Ruzhou First People's Hospital
Pingdingshan, China
Ye County People's Hospital
Pingdingshan, China
Pingdu Municipal People's Hospital
Pingdu, China
Anyang District Hospital
Pujiang, China
Chinese Medicine Hospital of puyang
Pujiang, China
Fanxian People's Hospital
Pujiang, China
Nanle County People's Hospital
Pujiang, China
Puyang People's Hospital
Pujiang, China
The Fifth People's Hospital of Puyang City
Pujiang, China
People's Hospital of Rizhao
Rizhao, China
Huanghe Sanmenxia Hospital
Sanmenxia, China
Sanmenxia Central Hospital
Sanmenxia, China
The First People's Hospital of Lingbao
Sanmenxia, China
The Sixth People's Hospital of Lingbao
Sanmenxia, China
Yimei Group General Hospital
Sanmenxia, China
Minquan County Hospital of Traditional Chinese Medicine
Shangqiu, China
Minquan County People's Hospital
Shangqiu, China
Second People's Hospital Xiayi Country
Shangqiu, China
Shangqiu Fourth People's Hospital
Shangqiu, China
Shangqiu Hospital of Traditional Chinese Medicine
Shangqiu, China
Shangqiu Municipal Hospital
Shangqiu, China
Shangqiu Third People's Hospital
Shangqiu, China
Sui County People's Hospital
Shangqiu, China
Suixian County Hospital of Traditional Chinese Medicine
Shangqiu, China
The First People's Hospital of Shangqiu
Shangqiu, China
The People's Hospital of Yucheng County
Shangqiu, China
Xiayi County People's Hospital
Shangqiu, China
Yongcheng Central Hospital
Shangqiu, China
Yucheng County People's Hospital
Shangqiu, China
Zhecheng People's Hospital
Shangqiu, China
Zhecheng Traditional Chinese Medicine Hospital Co., Ltd.
Shangqiu, China
Changyuan County People's Hospital
Xinxiang, China
Huixian People's Hospital
Xinxiang, China
The First Affiliated Hospital of Xinxiang Medical University
Xinxiang, China
The Third Affiliated Hospital of Xinxiang Medical University
Xinxiang, China
Xinxiang First People's Hospital
Xinxiang, China
Xinxiang Infectious Disease Hospital
Xinxiang, China
Yanjin County People's Hospital
Xinxiang, China
Guangshan County People's Hospital
Xinyang, China
Gushi County People's Hospital
Xinyang, China
Huaibin County People's Hospital
Xinyang, China
Huangchuan County People's Hospital
Xinyang, China
Luoshan County People's Hospital
Xinyang, China
Xinyang Central Hospital
Xinyang, China
Xinyang Specialized Hospital for Infectious Diseases
Xinyang, China
Xixian People's Hospital
Xinyang, China
Changge People's Hospital
Xuchang, China
Xiangcheng County Traditional Chinese Medicine Hospital
Xuchang, China
Xiangcheng People's Hospital
Xuchang, China
Xuchang Central Hospital
Xuchang, China
Xuchang People's Hospital
Xuchang, China
Yanling County People's Hospital
Xuchang, China
Yanling County Traditional Chinese Medicine Hospital
Xuchang, China
Yuzhou Central Hospital
Xuchang, China
Yuzhou City People's Hospital
Xuchang, China
Chinese People's Liberation Army Joint Logistics Support Force 970 Hospital,
Yantai, China
Jiaozuo People's Hospital
Yantai, China
Yantai Qishan Hospital
Yantai, China
Gongyi City People's Hospital
Zhengzhou, China
The First Affiliated Hospital of Henan University of Chinese Medicine
Zhengzhou, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, China
The First People's Hospit of Zhengzhou
Zhengzhou, China
The Second Affiliated Hospital of Zhengzhou University
Zhengzhou, China
The Six People's Hospit of Zhengzhou
Zhengzhou, China
The Third People's Hospit of Zhengzhou
Zhengzhou, China
Third Affiliated Hospital of Henan University of Traditional Chinese Medicine
Zhengzhou, China
Xingyang People's Hospital
Zhengzhou, China
Zhengzhou Central Hospital
Zhengzhou, China
Zhengzhou Traditional Chinese Medicine Hospital
Zhengzhou, China
Zhongmu County Hospital of Traditional Chinese Medicine
Zhengzhou, China
Zhongmu County People's Hospital
Zhengzhou, China
Zhongshan Second People's Hospital
Zhongshan, China
Dancheng County People's Hospital
Zhoukou, China
Fugou County People's Hospital
Zhoukou, China
Shenqiu People's Hospital
Zhoukou, China
Taikang County People's Hospital
Zhoukou, China
The Frist People's Hospital Of Xiangcheng
Zhoukou, China
The People's Hospital Of Luyi
Zhoukou, China
Xihua County Hospital of Traditional Chinese Medicine
Zhoukou, China
Xihua County People's Hospital
Zhoukou, China
Zhoukou Central Hospital
Zhoukou, China
Zhoukou Hospital Of TCM
Zhoukou, China
Zhoukou Specialized Disease Hospital
Zhoukou, China
People's Hospital of Queshan
Zhumadian, China
Pingyu County People's Hospital
Zhumadian, China
Runan County Hospital of Traditional Chinese Medicine
Zhumadian, China
Shangcai County People's Hospital
Zhumadian, China
The 990th Hospital of the Joint Logistics Support Force of the PLA
Zhumadian, China
The People's Hospital Of Biyang Country
Zhumadian, China
Xincai County People's Hospital
Zhumadian, China
Xincai Medical University
Zhumadian, China
Xiping County People's Hospital
Zhumadian, China
Zhengyang County People's Hospital
Zhumadian, China
Zhumadian Central Hospital
Zhumadian, China
Zhumadian Traditional Chinese Medicine Hospital
Zhumadian, China
Zibo Central Hospital
Zibo, China
Zibo Infectious Diseases Hospital (Zibo Fourth People's Hospital)
Zibo, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hongxia Liang
The First Affiliated Hospital of Zhengzhou University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief physician
Study Record Dates
First Submitted
June 24, 2025
First Posted
September 12, 2025
Study Start
June 3, 2024
Primary Completion (Estimated)
June 30, 2032
Study Completion (Estimated)
December 31, 2032
Last Updated
September 12, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share