A Real-World Study of Antiviral Therapy in Children With Chronic Hepatitis B
A Multicenter, Prospective, Real-World Study of Antiviral Therapy in Children With Chronic Hepatitis B
1 other identifier
observational
2,000
1 country
85
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2025
Typical duration for all trials
85 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
First Submitted
Initial submission to the registry
April 11, 2025
CompletedFirst Posted
Study publicly available on registry
April 14, 2025
CompletedStudy Start
First participant enrolled
May 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 15, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2028
April 29, 2025
April 1, 2025
3.6 years
April 11, 2025
April 28, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
HBsAg seroconversion rate
Week 48,96
Secondary Outcomes (5)
HBV DNA negative conversion rate
Week 48,96
HBeAg negative conversion rate
Week 48,96
HBeAg seroconversion rate
Week 48,96
HBsAg seroconversion rate
Week 48,96
ALT normalization rate
Week 48,96
Study Arms (2)
Initial Treatment Cohort 1
Previously Treated Cohort 1
Interventions
Administer NAs \[LAM, ETV, TDF, TAF (TAF preferred for those aged 6 years and older)\] continuously for 48 weeks based on age.
IFNα monotherapy for 48 weeks (select conventional IFNα for ages ≥1 and \<3 years, select PEG-IFNα-2b for ages ≥3 years)
Receive NAs combined with IFNα treatment for 48 weeks.
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)
Eligibility Criteria
The patients provided by hospitals from various centers across the country are standardized in English translation.
You may qualify if:
- Initial Treatment Group:
- 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.
- Age: ≥1 year and \<13 years, either sex;
- Positive for HBsAg and/or HBV DNA for more than 6 months;
- No prior antiviral treatment.
- Treated Group:
- 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.
- Age: ≥3 years and \<13 years, either sex;
- Previously diagnosed with chronic hepatitis B and received antiviral treatment with NAs for more than 1 year and currently on treatment;
- No history of IFNα use in the past 6 months;
- Negative for HBV DNA;
- HBsAg quantification \<10,000 IU/ml (HBsAg can be negative in the drug discontinuation observation group);
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (85)
Ankang Central Hospital
Ankang, China
Anyang Fifth People's Hospital
Anyang, China
Beihai People's Hospital
Beihai, China
301 Hospital
Beijing, China
Binzhou Medical University Affiliated Hospital
Binzhou, China
Changzhi Medical College Affiliated Peace Hospital
Changzhi, China
Changzhou Third People's Hospital
Changzhou, China
Chengdu Public Health Clinical Medical Center
Chengdu, China
West China Second Hospital, Sichuan University
Chengdu, China
The First Affiliated Hospital of Dalian Medical University
Dalian, China
Dongguan People's Hospital
Dongguan, China
Dongying People's Hospital
Dongying, China
Foshan First People's Hospital
Foshan, China
Southern Medical University Shunde Hospital
Foshan, China
Guangzhou Medical University Affiliated Women and Children's Medical Center
Guangzhou, China
The Third Affiliated Hospital of Guangzhou Medical University
Guangzhou, China
The Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, China
Hainan Women and Children's Medical Center
Haikou, China
Handan Infectious Disease Hospital
Handan, China
The First Affiliated Hospital of Anhui Medical University
Hefei, China
Hepu County People's Hospital
Hepu, China
Shanxian Central Hospital
Heze, China
Jiangmen Traditional Chinese Medicine Hospital
Jiangmen, China
Lanzhou Second People's Hospital
Lanzhou, China
Tibet Autonomous Region Third People's Hospital
Lhasa, China
Liaocheng People's Hospital
Liaocheng, China
Linfen People's Hospital
Linfen, China
Linfen Third People's Hospital
Linfen, China
Liuzhou Workers' Hospital
Liuchow, China
Longyan Second Hospital
Longyan, China
Luoyang Central Hospital
Luoyang, China
Southwest Medical University Affiliated Hospital
Luzhou, China
Jiangxi Children's Hospital
Nanchang, China
Nanchang Ninth Hospital
Nanchang, China
The First Affiliated Hospital of Nanchang University
Nanchang, China
The Second Affiliated Hospital of Nanchang University
Nanchang, China
Nanning Fourth People's Hospital
Nanning, China
The First Affiliated Hospital of Guangxi Medical University
Nanning, China
Nanyang Central Hospital
Nanyang, China
Affiliated Hospital of Putian University
Putian, China
Putian First Hospital
Putian, China
Qingdao Public Health Clinical Center
Qingdao, China
Quanzhou Maternal and Child Health Hospital Children's Hospital
Quanzhou, China
Queshan County People's Hospital
Queshan, China
Shangcheng County People's Hospital
Shangcheng, China
Shanghai Children's Hospital
Shanghai, China
Shangqiu City Hospital
Shangqiu, China
Shangqiu First People's Hospital
Shangqiu, China
Shangqiu Third People's Hospital
Shangqiu, China
Northern Guangdong Second People's Hospital
Shaoguan, China
Shenzhen Third People's Hospital
Shenzhen, China
The First Affiliated Hospital of Shihezi University
Shihezi, China
Handan Infectious Disease Hospital
Shijiazhuang, China
Shijiazhuang Fifth Hospital
Shijiazhuang, China
Suzhou Fifth People's Hospital
Suzhou, China
Shanxi Bethune Hospital
Taiyuan, China
Taiyuan Third People's Hospital
Taiyuan, China
Taian Central Hospital
Tai’an, China
The First Affiliated Hospital of Xinjiang Medical University
Ürümqi, China
Xinjiang Uygur Autonomous Region Infectious Diseases Hospital
Ürümqi, China
Weifang Medical University Affiliated Hospital
Weifang, China
Weishi County People's Hospital
Weishi, China
Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology
Wuhan, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, China
The Second Affiliated Hospital of Air Force Medical University (Tangdu Hospital)
Xi'an, China
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an, China
The First Affiliated Hospital of Xiamen University
Xiamen, China
Xiamen Traditional Chinese Medicine Hospital
Xiamen, China
Zhongshan Hospital Affiliated to Xiamen University
Xiamen, China
Liangshan Yi Autonomous Prefecture Seventh People's Hospital
Xichang, China
Qinghai Fourth People's Hospital
Xining, China
The First Affiliated Hospital of Xinxiang Medical University
Xinxiang, China
The Third Affiliated Hospital of Xinxiang Medical University
Xinxiang, China
Xixian People's Hospital
Xixian, China
Xuchang Central Hospital
Xuchang, China
Xuchang People's Hospital
Xuchang, China
Yantai Qishan Hospital
Yantai, China
Yongcheng People's Hospital
Yongcheng, China
Yulin Traditional Chinese Medicine Hospital
Yulin, China
Yulin Traditional Chinese Medicine Hospital
Yulin, China
Yuncheng Central Hospital
Yuncheng, China
The First Affiliated Hospital of Zhengzhou University
Zhenzhou, China
Zhongshan Second People's Hospital
Zhongshan, China
Zhumadian Central Hospital
Zhumadian, China
Zibo Infectious Diseases Hospital
Zibo, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Fusheng Wang
Fifth Medical Center of Chinese PLA General Hospital
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
April 11, 2025
First Posted
April 14, 2025
Study Start
May 1, 2025
Primary Completion (Estimated)
December 15, 2028
Study Completion (Estimated)
December 31, 2028
Last Updated
April 29, 2025
Record last verified: 2025-04
Data Sharing
- IPD Sharing
- Will not share