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AzTrials

Chronic Hepatitis bNCT07169656

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

An observational study of Chronic Hepatitis b, run by The First Affiliated Hospital of Zhengzhou University at 162 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Hepatitis b
What is being tested?
ETV,TDF,TAF,TMF and Peginterferon α-2b injection
Type of treatment
Injection or infusion
How many people
15,000 participants
Where
162 sitesChina
Study dates
3 Jun 2024to 31 Dec 2032
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

162 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Hongxia Liang contact

18595871806

hxliang@zzu.edu.cn

162 sites in 1 country

China162 sites, 162 recruiting

  • Huaxian People's Hospital

    Anyang

    Chongwei Hu

    Recruiting

  • Linzhou City People's Hospital

    Anyang

    Mingye Liu

    Recruiting

  • Neihuang County People's Hospital

    Anyang

    Jinxiu Li

    Recruiting

  • Tangyin County People's Hospital

    Anyang

    Fengge Yin

    Recruiting

  • The Fifth People's Hospital of Anyang

    Anyang

    Yuzhong Wang

    Recruiting

  • The First Affiliated Hospital of Xinxiang Medical University (Hua County Branch)

    Anyang

    Hengwei Ji

    Recruiting

  • Guangzhou First People's Hospital

    Guangzhou

    Qi Zhan

    Recruiting

  • The First Affiliated Hospital of Jinan University (Guangzhou Overseas Chinese Hospital)

    Guangzhou

    Xujing Liang

    Recruiting

  • Hebi Coal Mining Group General Hospital

    Hebi

    Zhanfeng Xie

    Recruiting

  • Hebi Infectious Disease Hospital

    Hebi

    Weili Niu

    Recruiting

  • Junxian County People's Hospital

    Hebi

    Yunli Jia

    Recruiting

  • Bo'ai County People's Hospital

    Jiaozuo

    Daqing Guo

    Recruiting

  • Mengzhou Hospital of Traditional Chinese Medicine

    Jiaozuo

    Zengyuan Fu

    Recruiting

  • Qinyang People's Hospital

    Jiaozuo

    Donghai Chen

    Recruiting

  • The Secend People's Hospital of Jiaozuo

    Jiaozuo

    Yuliang Zhao

    Recruiting

  • The Third People's Hospital of Jiaozuo

    Jiaozuo

    Zhiqi Han

    Recruiting

  • Xiuwu People's Hospital

    Jiaozuo

    Chao Zhang

    Recruiting

  • Wenxian People's Hospital

    Jiayuguan

    Guoqing Chen

    Recruiting

  • Jiyang County Hospital of Traditional Chinese Medicine

    Jinan

    Jian Yao

    Recruiting

  • Shandong Public Health Clinical Center

    Jinan

    Xiaoying Li

    Recruiting

  • Jiyuan People's Hospital

    Jiyuan

    Chao Liang

    Recruiting

  • Jiyuan Traditional Chinese Medicine Hospital

    Jiyuan

    Yuye Wu

    Recruiting

  • Huaihe Hospital of Henan University

    Kaifeng

    Zhenkun He

    Recruiting

  • Infectious Diseases Hospital of Kaifeng

    Kaifeng

    Peng Lei

    Recruiting

  • Kaifeng Central Hospital

    Kaifeng

    Yong'an Zhou

    Recruiting

  • Kaifeng Hospital of Traditional Chinese Medicine

    Kaifeng

    Qinghua Zhao

    Recruiting

  • Lankao First Hospital Group

    Kaifeng

    Bing Zhang

    Recruiting

  • Qixian People's Hospital

    Kaifeng

    Xuelong Liang

    Recruiting

  • The People's Hospital of Weishi

    Kaifeng

    Kaiqin Liu

    Recruiting

  • Tongxu County People's Hospital

    Kaifeng

    Ying Tang

    Recruiting

  • Weishi County People's Hospital

    Kaifeng

    Hongxia Zhu

    Recruiting

  • Linyi Hospital of Traditional Chinese Medicine

    Linyi

    Hezheng Shen

    Recruiting

  • Linyi People's Hospital

    Linyi

    Feng Gao

    Recruiting

  • Linying County People's Hospital

    Luohe

    Yadong Xing

    Recruiting

  • Luohe Central Hospital

    Luohe

    Yuli Meng

    Recruiting

  • Luanchuan County People's Hospital

    Luoyang

    Guangsong Li

    Recruiting

  • Luoning County People's Hospital

    Luoyang

    Xiubin Hao

    Recruiting

  • Luoyang Central Hospital

    Luoyang

    Guoqiang Zhang

    Recruiting

  • Luoyang First People's Hospital

    Luoyang

    Hua Li

    Recruiting

  • Luoyang Third People's Hospital

    Luoyang

    Hongbo Ji

    Recruiting

  • Ruyang County People's Hospital

    Luoyang

    Xianwei Shang

    Recruiting

  • The First Affiliated Hospital of Henan University of Science and Technology

    Luoyang

    Xinjun Hu

    Recruiting

  • Xin'an County People's Hospital

    Luoyang

    Lanfen Bai

    Recruiting

  • Yichuan County Hospital of Traditional Chinese Medicine

    Luoyang

    Xinshui Ye

    Recruiting

  • Yiyang County People's Hospital

    Luoyang

    Yaohuan Li

    Recruiting

  • Dengzhou Central Hospital

    Nanyang

    Chunge Tian

    Recruiting

  • Dengzhou People's Hospital

    Nanyang

    Xinghong Peng

    Recruiting

  • Fangcheng County People's Hospital

    Nanyang

    Dong Wang

    Recruiting

  • Nanyang Central Hospital

    Nanyang

    Xizeng Zhu

    Recruiting

  • Nanyang First People's Hospital

    Nanyang

    Daimeng Shi

    Recruiting

  • Nanyang Oilfield General Hospital

    Nanyang

    Qiaoli Yu

    Recruiting

  • Nanyang Second General Hospital

    Nanyang

    Xuexiang Wang

    Recruiting

  • Nanzhao County People's Hospital

    Nanyang

    Changliang Huang

    Recruiting

  • Neixiang County People's Hospital

    Nanyang

    Xiaobo Li

    Recruiting

  • Sheqi County People's Hospital

    Nanyang

    Qinglin Zhou

    Recruiting

  • Tanghe County People's Hospital

    Nanyang

    Hongxun He

    Recruiting

  • The First Affiliated Hospital of Nanyang Medical College

    Nanyang

    Yu Zhang

    Recruiting

  • Xinye County People's Hospital

    Nanyang

    Ruichao Li

    Recruiting

  • Xixia County People's Hospital

    Nanyang

    Yongling Qiao

    Recruiting

  • Zhenping People's Hospital

    Nanyang

    Liguo Yang

    Recruiting

  • Ningbo Medical Center Iihuili hospital

    Ningbo

    Hua Ye

    Recruiting

  • General Hospital Of Pingmei Shenma Group

    Pingdingshan

    Guodong Zhang

    Recruiting

  • Lushan County People's Hospital

    Pingdingshan

    Yin Liu

    Recruiting

  • People's Hospital of Baofeng

    Pingdingshan

    Zengyan Yang

    Recruiting

  • Pingdingshan First People's Hospital

    Pingdingshan

    Hongde Ma

    Recruiting

  • Ruzhou First People's Hospital

    Pingdingshan

    Dongdong Yang

    Recruiting

  • Ye County People's Hospital

    Pingdingshan

    Lin Zhou

    Recruiting

  • Pingdu Municipal People's Hospital

    Pingdu

    Shuilin Wang

    Recruiting

  • Anyang District Hospital

    Pujiang

    Shuli Jin

    Recruiting

  • Chinese Medicine Hospital of puyang

    Pujiang

    Jing Wang

    Recruiting

  • Fanxian People's Hospital

    Pujiang

    Xianliang Sang

    Recruiting

  • Nanle County People's Hospital

    Pujiang

    Zhibo Ren

    Recruiting

  • Puyang People's Hospital

    Pujiang

    Xiangan Song

    Recruiting

  • The Fifth People's Hospital of Puyang City

    Pujiang

    Weina Zhang

    Recruiting

  • People's Hospital of Rizhao

    Rizhao

    Tao Ding

    Recruiting

  • Huanghe Sanmenxia Hospital

    Sanmenxia

    Huanhuan Su

    Recruiting

  • Sanmenxia Central Hospital

    Sanmenxia

    Xiaoping Dong

    Recruiting

  • The First People's Hospital of Lingbao

    Sanmenxia

    Nana Meng

    Recruiting

  • The Sixth People's Hospital of Lingbao

    Sanmenxia

    Wanfeng Wang

    Recruiting

  • Yimei Group General Hospital

    Sanmenxia

    Jihong Li

    Recruiting

  • Minquan County Hospital of Traditional Chinese Medicine

    Shangqiu

    Shifeng Han

    Recruiting

  • Minquan County People's Hospital

    Shangqiu

    Yong Cui

    Recruiting

  • Second People's Hospital Xiayi Country

    Shangqiu

    Jingwen Sun

    Recruiting

  • Shangqiu Fourth People's Hospital

    Shangqiu

    Fajun Jia

    Recruiting

  • Shangqiu Hospital of Traditional Chinese Medicine

    Shangqiu

    Xiaolei Zhu

    Recruiting

  • Shangqiu Municipal Hospital

    Shangqiu

    Shixi Zhang

    Recruiting

  • Shangqiu Third People's Hospital

    Shangqiu

    Kun Lu

    Recruiting

  • Sui County People's Hospital

    Shangqiu

    Yanling Yang

    Recruiting

  • Suixian County Hospital of Traditional Chinese Medicine

    Shangqiu

    Hongbo Wang

    Recruiting

  • The First People's Hospital of Shangqiu

    Shangqiu

    Yaqing Liu

    Recruiting

  • The People's Hospital of Yucheng County

    Shangqiu

    Shengli Ma

    Recruiting

  • Xiayi County People's Hospital

    Shangqiu

    Yu Zhao

    Recruiting

  • Yongcheng Central Hospital

    Shangqiu

    Houfeng Zhai

    Recruiting

  • Yucheng County People's Hospital

    Shangqiu

    Mintian Wu

    Recruiting

  • Zhecheng People's Hospital

    Shangqiu

    Jianguo Wang

    Recruiting

  • Zhecheng Traditional Chinese Medicine Hospital Co., Ltd.

    Shangqiu

    Caiying Luo

    Recruiting

  • Changyuan County People's Hospital

    Xinxiang

    Wuxue Niu

    Recruiting

  • Huixian People's Hospital

    Xinxiang

    Fuqiang Li

    Recruiting

  • The First Affiliated Hospital of Xinxiang Medical University

    Xinxiang

    Daokun Yang

    Recruiting

  • The Third Affiliated Hospital of Xinxiang Medical University

    Xinxiang

    Qian Dou

    Recruiting

  • Xinxiang First People's Hospital

    Xinxiang

    Yali Yang

    Recruiting

  • Xinxiang Infectious Disease Hospital

    Xinxiang

    Zhengyan Wen

    Recruiting

  • Yanjin County People's Hospital

    Xinxiang

    Gaoxian Li

    Recruiting

  • Guangshan County People's Hospital

    Xinyang

    Zhaohai Zeng

    Recruiting

  • Gushi County People's Hospital

    Xinyang

    Mingren Shi

    Recruiting

  • Huaibin County People's Hospital

    Xinyang

    Jianye Ding

    Recruiting

  • Huangchuan County People's Hospital

    Xinyang

    Jianhong Wu

    Recruiting

  • Luoshan County People's Hospital

    Xinyang

    Jianzhi Gu

    Recruiting

  • Xinyang Central Hospital

    Xinyang

    Haiyan Chen

    Recruiting

  • Xinyang Specialized Hospital for Infectious Diseases

    Xinyang

    Honglei Li

    Recruiting

  • Xixian People's Hospital

    Xinyang

    Wenhua Zhai

    Recruiting

  • Changge People's Hospital

    Xuchang

    Huage Zhao

    Recruiting

  • Xiangcheng County Traditional Chinese Medicine Hospital

    Xuchang

    Jianhong Yang

    Recruiting

  • Xiangcheng People's Hospital

    Xuchang

    Xueqin Yan

    Recruiting

  • Xuchang Central Hospital

    Xuchang

    Weihong Li

    Recruiting

  • Xuchang People's Hospital

    Xuchang

    Xia Zhang

    Recruiting

  • Yanling County People's Hospital

    Xuchang

    Wei Zhang

    Recruiting

  • Yanling County Traditional Chinese Medicine Hospital

    Xuchang

    Yongzhen Tian

    Recruiting

  • Yuzhou Central Hospital

    Xuchang

    Qianqian Chen

    Recruiting

  • Yuzhou City People's Hospital

    Xuchang

    Hongmin Si

    Recruiting

  • Chinese People's Liberation Army Joint Logistics Support Force 970 Hospital,

    Yantai

    Yi Zhao

    Recruiting

  • Jiaozuo People's Hospital

    Yantai

    Jikang Yang

    Recruiting

  • Yantai Qishan Hospital

    Yantai

    Haifeng Yu

    Recruiting

  • Gongyi City People's Hospital

    Zhengzhou

    Li Yang

    Recruiting

  • The First Affiliated Hospital of Henan University of Chinese Medicine

    Zhengzhou

    Suping Ma

    Recruiting

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou

    Huijiang Yu

    Recruiting

  • The First People's Hospit of Zhengzhou

    Zhengzhou

    Shujun Wang

    Recruiting

  • The Second Affiliated Hospital of Zhengzhou University

    Zhengzhou

    Gaofeng Lu

    Recruiting

  • The Six People's Hospit of Zhengzhou

    Zhengzhou

    Guangming Li

    Recruiting

  • The Third People's Hospit of Zhengzhou

    Zhengzhou

    Dan Zhao

    Recruiting

  • Third Affiliated Hospital of Henan University of Traditional Chinese Medicine

    Zhengzhou

    Yansheng Li

    Recruiting

  • Xingyang People's Hospital

    Zhengzhou

    Gaoyu Chen

    Recruiting

  • Zhengzhou Central Hospital

    Zhengzhou

    Huili Wu

    Recruiting

  • Zhengzhou Traditional Chinese Medicine Hospital

    Zhengzhou

    Hongwei Luo

    Recruiting

  • Zhongmu County Hospital of Traditional Chinese Medicine

    Zhengzhou

    Guoqiang Liang

    Recruiting

  • Zhongmu County People's Hospital

    Zhengzhou

    Qiaoxia Chen

    Recruiting

  • Zhongshan Second People's Hospital

    Zhongshan

    Qianhua Zhang

    Recruiting

  • Dancheng County People's Hospital

    Zhoukou

    Qi Yang

    Recruiting

  • Fugou County People's Hospital

    Zhoukou

    Baoping Xu

    Recruiting

  • Shenqiu People's Hospital

    Zhoukou

    Xianyang Li

    Recruiting

  • Taikang County People's Hospital

    Zhoukou

    Xueqiang Liu

    Recruiting

  • The Frist People's Hospital Of Xiangcheng

    Zhoukou

    Hongwei Wang

    Recruiting

  • The People's Hospital Of Luyi

    Zhoukou

    Gaoju Li

    Recruiting

  • Xihua County Hospital of Traditional Chinese Medicine

    Zhoukou

    Rui Yin

    Recruiting

  • Xihua County People's Hospital

    Zhoukou

    Yanfang Zou

    Recruiting

  • Zhoukou Central Hospital

    Zhoukou

    Jiaqi Zhang

    Recruiting

  • Zhoukou Hospital Of TCM

    Zhoukou

    Jiawei Zhang

    Recruiting

  • Zhoukou Specialized Disease Hospital

    Zhoukou

    Mengshan Jia

    Recruiting

  • People's Hospital of Queshan

    Zhumadian

    Ruinian Zhang

    Recruiting

  • Pingyu County People's Hospital

    Zhumadian

    Jingzhen Zhang

    Recruiting

  • Runan County Hospital of Traditional Chinese Medicine

    Zhumadian

    Junling Han

    Recruiting

  • Shangcai County People's Hospital

    Zhumadian

    Weiping Li

    Recruiting

  • The 990th Hospital of the Joint Logistics Support Force of the PLA

    Zhumadian

    Chun Yuan

    Recruiting

  • The People's Hospital Of Biyang Country

    Zhumadian

    Wei Zhang

    Recruiting

  • Xincai County People's Hospital

    Zhumadian

    Shumei Guo

    Recruiting

  • Xincai Medical University

    Zhumadian

    Daliang Yang

    Recruiting

  • Xiping County People's Hospital

    Zhumadian

    Junping Chen

    Recruiting

  • Zhengyang County People's Hospital

    Zhumadian

    Minghui Yu

    Recruiting

  • Zhumadian Central Hospital

    Zhumadian

    Guifu Shi

    Recruiting

  • Zhumadian Traditional Chinese Medicine Hospital

    Zhumadian

    Yufu Wang

    Recruiting

  • Zibo Central Hospital

    Zibo

    Yanqing Xing

    Recruiting

  • Zibo Infectious Diseases Hospital (Zibo Fourth People's Hospital)

    Zibo

    Gang Li

    Recruiting

Other trials in China

About this study

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.

Being tested
ETV,TDF,TAF,TMF, Peginterferon α-2b injection
Medical subject headings
Hepatitis B, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ETV,TDF,TAF,TMFDrug

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

  • Peginterferon α-2b injectionDrug

    treated with Peginterferon α-2b injection

Study groups in NCT07169656
Study groupRoleWhat they receive
Group 1Not described
Receives: Drug: ETV,TDF,TAF,TMF
Group 2Not described
Receives: Drug: Peginterferon α-2b injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of patients with HBsAg-associated HCC post-therapy

    Measured: Week 4-240

  2. Hepatocellular Carcinoma (HCC) Incidence

    Measured: Week 4-240

Secondary outcomes (13)

  1. Number of chronic hepatitis B (CHB) patients with accurate knowledge/awareness of HBV

    Measured: Week 4-240

  2. Rate of HBsAg seroclearance

    Measured: Week 4-240

  3. HBsAg seroconversion rate

    Measured: Week 4-240

  4. Number of patients with altered HBsAg levels post-treatment

    Measured: Week 4-240

  5. Number of patients with HBsAg level decline from baseline

    Measured: Week 4-240

  6. HBeAg seroconversion rate

    Measured: Week 4-240

  7. HBV DNA

    Measured: Week 4-240

  8. Liver fibrosis improvement rate

    Measured: Week 4-240

  9. Incidence of liver cirrhosis

    Measured: Week 4-240

  10. Incidence of decompensated cirrhosis

    Measured: Week 4-240

  11. Incidence of decompensation-related complications

    Measured: Week 4-240

  12. Liver transplantation incidence rate

    Measured: Week 4-240

  13. Post-treatment relapse rate

    Measured: Week 4-240

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Sep 2025
  2. Study start3 Jun 2024
  3. Primary completion30 Jun 2032 (estimated)
  4. Study completion31 Dec 2032 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
15,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07169656
Sponsor's protocol ID
2024-KY-0976-001
Status last verified
Sep 2025
First submitted
24 Jun 2025
Last updated
12 Sep 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Chronic Hepatitis b, run by The First Affiliated Hospital of Zhengzhou University at 162 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 12 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 162 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Hongxia Liang (18595871806, hxliang@zzu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of patients with HBsAg-associated HCC post-therapy (time frame: Week 4-240). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07169656.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2025.

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