A Real-World Study of Antiviral Therapy in Children With Chronic Hepatitis B

April 28, 2025 updated by: Fu-Sheng Wang, Beijing 302 Hospital

A Multicenter, Prospective, Real-World Study of Antiviral Therapy in Children With Chronic Hepatitis B

This is a multicenter, prospective, real-world study. The study plans to include a total of 2000 patients who meet the inclusion and exclusion criteria, consisting of 1600 treatment-naive patients and 400 treatment-experienced patients. The effectiveness and safety of different treatment strategies will be evaluated in children aged 1-12 years with treatment-naive and treatment-experienced chronic hepatitis B (CHB) and chronic HBV infection.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Ankang, China
        • Ankang Central Hospital
        • Contact:
          • Bing Li
      • Anyang, China
        • Anyang Fifth People's Hospital
        • Contact:
          • Aiqin Hao
      • Beihai, China
        • Beihai People's Hospital
        • Contact:
          • Feng Long
      • Beijing, China
        • 301 Hospital
        • Contact:
          • Yongmei Lin
      • Binzhou, China
        • Binzhou Medical University Affiliated Hospital
        • Contact:
          • Tonggang Liu
      • Changzhi, China
        • Changzhi Medical College Affiliated Peace Hospital
        • Contact:
          • Suling Chen
      • Changzhou, China
        • Changzhou Third People's Hospital
        • Contact:
          • Chunyan Ye
      • Chengdu, China
        • Chengdu Public Health Clinical Medical Center
        • Contact:
          • Li Zhu
      • Chengdu, China
        • West China Second Hospital, Sichuan University
        • Contact:
          • Yu Zhu
      • Dalian, China
        • The First Affiliated Hospital of Dalian Medical University
        • Contact:
          • Ying Zhu
      • Dongguan, China
        • Dongguan People's Hospital
        • Contact:
          • Songmei He
      • Dongying, China
        • Dongying People's Hospital
        • Contact:
          • Pengyan Li
      • Foshan, China
        • Foshan First People's Hospital
        • Contact:
          • Honglian Bai
      • Foshan, China
        • Southern Medical University Shunde Hospital
        • Contact:
          • Hong Li
      • Guangzhou, China
        • The Third Affiliated Hospital of Guangzhou Medical University
        • Contact:
          • Xingfei Pan
      • Guangzhou, China
        • The Third Affiliated Hospital of Sun Yat-Sen University
        • Contact:
          • Bingliang Lin
      • Guangzhou, China
        • Guangzhou Medical University Affiliated Women and Children's Medical Center
        • Contact:
          • Yi Xu
      • Haikou, China
        • Hainan Women and Children's Medical Center
        • Contact:
          • Daojiong Lin
      • Handan, China
        • Handan Infectious Disease Hospital
        • Contact:
          • Hongxia Zhou
      • Hefei, China
        • The First Affiliated Hospital of Anhui Medical University
        • Contact:
          • Yufeng Gao
      • Hepu, China
        • Hepu County People's Hospital
        • Contact:
          • Lundong Wu
      • Heze, China
        • Shanxian Central Hospital
        • Contact:
          • Jian Liu
      • Jiangmen, China
        • Jiangmen Traditional Chinese Medicine Hospital
        • Contact:
          • Gang He
      • Lanzhou, China
        • Lanzhou Second People's Hospital
        • Contact:
          • Wenjuan Shi
      • Lhasa, China
        • Tibet Autonomous Region Third People's Hospital
        • Contact:
          • Bayangzhen Bian
      • Liaocheng, China
        • Liaocheng People's Hospital
        • Contact:
          • Sikui Wang
      • Linfen, China
        • Linfen People's Hospital
        • Contact:
          • Feng Gao
      • Linfen, China
        • Linfen Third People's Hospital
        • Contact:
          • Xiufang Du
      • Liuzhou, China
        • Liuzhou Workers' Hospital
        • Contact:
          • Qian Guo
      • Longyan, China
        • Longyan Second Hospital
        • Contact:
          • Qingdong Tong
      • Luoyang, China
        • Luoyang Central Hospital
        • Contact:
          • Guoqiang Zhang
      • Luzhou, China
        • Southwest Medical University Affiliated Hospital
        • Contact:
          • Cunliang Deng
      • Nanchang, China
        • The First Affiliated Hospital of NanChang University
        • Contact:
          • Xiaoping Wu
      • Nanchang, China
        • The Second Affiliated Hospital of Nanchang University
        • Contact:
          • Shuilin Sun
      • Nanchang, China
        • Jiangxi Children's Hospital
        • Contact:
          • Chunhui Zhu
      • Nanchang, China
        • Nanchang Ninth Hospital
        • Contact:
          • Hongyi Chen
      • Nanning, China
        • The First Affiliated Hospital of Guangxi Medical University
        • Contact:
          • Qingwen Shan
      • Nanning, China
        • Nanning Fourth People's Hospital
        • Contact:
          • Fen Li
      • Nanyang, China
        • Nanyang Central Hospital
        • Contact:
          • Yuzhuo Wu
      • Putian, China
        • Affiliated Hospital of Putian University
        • Contact:
          • Rongxian Qiu
      • Putian, China
        • Putian First Hospital
        • Contact:
          • Boqi Guo
      • Qingdao, China
        • Qingdao Public Health Clinical Center
        • Contact:
          • RenDong Wei
      • Quanzhou, China
        • Quanzhou Maternal and Child Health Hospital Children's Hospital
        • Contact:
          • Junfeng Wu
      • Queshan, China
        • Queshan County People's Hospital
        • Contact:
          • Ruinian Zhang
      • Shangcheng, China
        • Shangcheng County People's Hospital
        • Contact:
          • Chuanwen Chen
      • Shanghai, China
        • Shanghai Children's Hospital
      • Shangqiu, China
        • Shangqiu City Hospital
        • Contact:
          • Wenliang Zhou
      • Shangqiu, China
        • Shangqiu First People's Hospital
        • Contact:
          • Yaqing Liu
      • Shangqiu, China
        • Shangqiu Third People's Hospital
        • Contact:
          • Kun Lu
      • Shaoguan, China
        • Northern Guangdong Second People's Hospital
        • Contact:
          • Zhijiao Xiong
      • Shenzhen, China
        • Shenzhen Third People's Hospital
        • Contact:
          • Fang Wang
      • Shihezi, China
        • The First Affiliated Hospital of Shihezi University
        • Contact:
          • Songsong Xie
      • Shijiazhuang, China
        • Shijiazhuang Fifth Hospital
        • Contact:
          • Bo LI
      • Shijiazhuang, China
        • Handan Infectious Disease Hospital
        • Contact:
          • Xinli Bai
      • Suzhou, China
        • Suzhou Fifth People's Hospital
        • Contact:
          • Chuanwu Zhu
      • Tai'an, China
        • Taian Central Hospital
        • Contact:
          • Yang Feng
      • Taiyuan, China
        • Shanxi Bethune Hospital
        • Contact:
          • Yan Wang
      • Taiyuan, China
        • Taiyuan Third People's Hospital
        • Contact:
          • Ying Guo
      • Weifang, China
        • Weifang Medical University Affiliated Hospital
        • Contact:
          • Jing Feng
      • Weishi, China
        • Weishi County People's Hospital
        • Contact:
          • Xiangyang Li
      • Wuhan, China
        • Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
        • Contact:
          • Sainan Shu
      • Xi'an, China
        • The First Affiliated Hospital of Xi'an Jiaotong University
        • Contact:
          • Yingli He
      • Xi'an, China
        • The Second Affiliated Hospital of Xi'an Jiaotong University
        • Contact:
          • Shuangsuo Dang
      • Xi'an, China
        • The Second Affiliated Hospital of Air Force Medical University (Tangdu Hospital)
        • Contact:
          • Wen Tang
      • Xiamen, China
        • The First Affiliated Hospital of Xiamen University
        • Contact:
          • Xiulan Xue
      • Xiamen, China
        • Zhongshan Hospital Affiliated to Xiamen University
        • Contact:
          • Ling Chen
      • Xiamen, China
        • Xiamen Traditional Chinese Medicine Hospital
        • Contact:
          • Qingfa Luan
      • Xichang, China
        • Liangshan Yi Autonomous Prefecture Seventh People's Hospital
        • Contact:
          • Min Fang
      • Xining, China
        • Qinghai Fourth People's Hospital
        • Contact:
          • Haifang Cao
      • Xinxiang, China
        • The First Affiliated Hospital of Xinxiang Medical University
        • Contact:
          • Daokun Yang
      • Xinxiang, China
        • The Third Affiliated Hospital of Xinxiang Medical University
        • Contact:
          • Qian Dou
      • Xixian, China
        • Xixian People's Hospital
        • Contact:
          • Wenhua Zhai
      • Xuchang, China
        • Xuchang Central Hospital
        • Contact:
          • Weihong Li
      • Xuchang, China
        • Xuchang People's Hospital
        • Contact:
          • Xia Zhang
      • Yantai, China
        • Yantai Qishan Hospital
        • Contact:
          • Haifeng Yu
      • Yongcheng, China
        • Yongcheng People's Hospital
        • Contact:
          • Shengli Ma
      • Yulin, China
        • Yulin Traditional Chinese Medicine Hospital
        • Contact:
          • Wuhai Tan
      • Yuncheng, China
        • Yuncheng Central Hospital
        • Contact:
          • Lijun Chang
      • Zhenzhou, China
        • The First Affiliated Hospital of Zhengzhou University
        • Contact:
          • Hongxia Ran
      • Zhongshan, China
        • Zhongshan Second People's Hospital
        • Contact:
          • Qianhua Zhang
      • Zhumadian, China
        • Zhumadian Central Hospital
        • Contact:
          • Guifu Shi
      • Zibo, China
        • Zibo Infectious Diseases Hospital
        • Contact:
          • Huibin chu
      • Ürümqi, China
        • The first affiliated hospital of Xinjiang medical university
        • Contact:
          • Lu Xiaoqing
      • Ürümqi, China
        • Xinjiang Uygur Autonomous Region Infectious Diseases Hospital
        • Contact:
          • Jiang Maimaiti

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The patients provided by hospitals from various centers across the country are standardized in English translation.

Description

Inclusion Criteria:

  • Initial Treatment Group:

    1. The guardian understands and signs the informed consent form (both parents must sign), and adheres to the relevant requirements of this study. If the participant is 8 years old or older, they must also sign the informed consent form. For participants under 8 years old who can express consent, their consent must be clearly documented.
    2. Age: ≥1 year and <13 years, either sex;
    3. Positive for HBsAg and/or HBV DNA for more than 6 months;
    4. No prior antiviral treatment.

  • Treated Group:

    1. The guardian understands and signs the informed consent form (both parents must sign), and adheres to the relevant requirements of this study. If the participant is 8 years old or older, they must also sign the informed consent form. For participants under 8 years old who can express consent, their consent must be clearly documented.
    2. Age: ≥3 years and <13 years, either sex;
    3. Previously diagnosed with chronic hepatitis B and received antiviral treatment with NAs for more than 1 year and currently on treatment;
    4. No history of IFNα use in the past 6 months;
    5. Negative for HBV DNA;
    6. HBsAg quantification <10,000 IU/ml (HBsAg can be negative in the drug discontinuation observation group);
    7. The drug discontinuation observation group must also achieve negative HBV DNA and HBeAg seroconversion for at least 1 year (based on continuous results from three consecutive reviews), and HBsAg <10,000 IU/ml; NAs will be discontinued after enrollment.

Exclusion Criteria:

  • 1.In the interferon group, blood white blood cell count <3.5×10^9/L, or platelet count <80×10^9/L, or prothrombin activity <60%, or total bilirubin >34μmol/L, or serum albumin <35g/L, or serum creatinine >133μmol/L; 2.Coexistence of other active infections; 3. Coexistence of other chronic liver diseases or active liver diseases, such as autoimmune liver disease, drug-induced liver injury, Wilson's disease, decompensated cirrhosis, liver cancer; 4. Coexistence of other severe systemic diseases or malignant tumors, etc.; 5. History of allergy to nucleoside analogues or interferon; 6. Subjects whom the investigator deems to have poor compliance, unable or unwilling to provide informed consent, or unable to adhere to the study requirements, or other conditions not suitable for participation in this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Initial Treatment Cohort 1
Drug: Nucleos(t)ide Analogues
Administer NAs [LAM, ETV, TDF, TAF (TAF preferred for those aged 6 years and older)] continuously for 48 weeks based on age.
Drug: Interferon alfa
IFNα monotherapy for 48 weeks (select conventional IFNα for ages ≥1 and <3 years, select PEG-IFNα-2b for ages ≥3 years)
Drug: NAs combined with IFNα
Receive NAs combined with IFNα treatment for 48 weeks.
Other: comparative observation
Blank control observation for 48 weeks.
Previously Treated Cohort 1
Drug: Nucleos(t)ide Analogues
Administer NAs [LAM, ETV, TDF, TAF (TAF preferred for those aged 6 years and older)] continuously for 48 weeks based on age.
Drug: NAs combined with IFNα
Receive NAs combined with IFNα treatment for 48 weeks.
Other: drug withdrawal observation
This group is the drug withdrawal observation group, which will strictly monitor virological indicators and biochemical results, and will reinitiate antiviral treatment if necessary based on antiviral treatment standards and the willingness of the child (or family members)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
HBsAg seroconversion rate
Time Frame: Week 48,96
Week 48,96

Secondary Outcome Measures

Outcome Measure
Time Frame
HBsAg seroconversion rate
Time Frame: Week 48,96
Week 48,96
HBV DNA negative conversion rate
Time Frame: Week 48,96
Week 48,96
HBeAg negative conversion rate
Time Frame: Week 48,96
Week 48,96
HBeAg seroconversion rate
Time Frame: Week 48,96
Week 48,96
ALT normalization rate
Time Frame: Week 48,96
Week 48,96

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing 302 Hospital

Investigators

  • Study Director: Fusheng Wang, Fifth Medical Center of Chinese PLA General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2025

Primary Completion (Estimated)

December 15, 2028

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

April 11, 2025

First Submitted That Met QC Criteria

April 11, 2025

First Posted (Actual)

April 14, 2025

Study Record Updates

Last Update Posted (Actual)

April 29, 2025

Last Update Submitted That Met QC Criteria

April 28, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY-2025-2-31-2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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