A Real-World Study of Antiviral Therapy in Children With Chronic Hepatitis B
NCT ID: NCT06926647
Last Updated: 2025-04-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
2000 participants
OBSERVATIONAL
2025-05-01
2028-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Initial Treatment Cohort 1
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.
Interferon alfa
IFNα monotherapy for 48 weeks (select conventional IFNα for ages ≥1 and \<3 years, select PEG-IFNα-2b for ages ≥3 years)
NAs combined with IFNα
Receive NAs combined with IFNα treatment for 48 weeks.
comparative observation
Blank control observation for 48 weeks.
Previously Treated Cohort 1
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.
NAs combined with IFNα
Receive NAs combined with IFNα treatment for 48 weeks.
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)
Interventions
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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.
Interferon alfa
IFNα monotherapy for 48 weeks (select conventional IFNα for ages ≥1 and \<3 years, select PEG-IFNα-2b for ages ≥3 years)
NAs combined with IFNα
Receive NAs combined with IFNα treatment for 48 weeks.
comparative observation
Blank control observation for 48 weeks.
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)
Eligibility Criteria
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Inclusion Criteria
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 Year
13 Years
ALL
No
Sponsors
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Beijing 302 Hospital
OTHER
Responsible Party
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Fu-Sheng Wang
Chief physician
Principal Investigators
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Fusheng Wang
Role: STUDY_DIRECTOR
Fifth Medical Center of Chinese PLA General Hospital
Locations
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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
Liuzhou, , 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
Countries
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Central Contacts
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Facility Contacts
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Shuilin Sun
Role: primary
Fen Li
Role: primary
Qingwen Shan
Role: primary
Yuzhuo Wu
Role: primary
Rongxian Qiu
Role: primary
Boqi Guo
Role: primary
RenDong Wei
Role: primary
Junfeng Wu
Role: primary
Ruinian Zhang
Role: primary
Chuanwen Chen
Role: primary
Wenliang Zhou
Role: primary
Yaqing Liu
Role: primary
Kun Lu
Role: primary
Zhijiao Xiong
Role: primary
Fang Wang
Role: primary
Songsong Xie
Role: primary
Xinli Bai
Role: primary
Bo Li
Role: primary
Chuanwu Zhu
Role: primary
Yan Wang
Role: primary
Ying Guo
Role: primary
Yang Feng
Role: primary
Lu Xiaoqing
Role: primary
Jiang Maimaiti
Role: primary
Jing Feng
Role: primary
Xiangyang Li
Role: primary
Sainan Shu
Role: primary
Yingli He
Role: primary
Wen Tang
Role: primary
Shuangsuo Dang
Role: primary
Xiulan Xue
Role: primary
Qingfa Luan
Role: primary
Ling Chen
Role: primary
Min Fang
Role: primary
Haifang Cao
Role: primary
Daokun Yang
Role: primary
Qian Dou
Role: primary
Wenhua Zhai
Role: primary
Weihong Li
Role: primary
Xia Zhang
Role: primary
Haifeng Yu
Role: primary
Shengli Ma
Role: primary
Fanrong Liu
Role: primary
Wuhai Tan
Role: primary
Lijun Chang
Role: primary
Hongxia Ran
Role: primary
Qianhua Zhang
Role: primary
Guifu Shi
Role: primary
Huibin chu
Role: primary
Bing Li
Role: primary
Aiqin Hao
Role: primary
Feng Long
Role: primary
Yongmei Lin
Role: primary
Tonggang Liu
Role: primary
Suling Chen
Role: primary
Chunyan Ye
Role: primary
Li Zhu
Role: primary
Yu Zhu
Role: primary
Ying Zhu
Role: primary
Songmei He
Role: primary
Pengyan Li
Role: primary
Honglian Bai
Role: primary
Hong Li
Role: primary
Yi Xu
Role: primary
Xingfei Pan
Role: primary
Bingliang Lin
Role: primary
Daojiong Lin
Role: primary
Hongxia Zhou
Role: primary
Yufeng Gao
Role: primary
Lundong Wu
Role: primary
Jian Liu
Role: primary
Gang He
Role: primary
Wenjuan Shi
Role: primary
Bayangzhen Bian
Role: primary
Sikui Wang
Role: primary
Feng Gao
Role: primary
Xiufang Du
Role: primary
Qian Guo
Role: primary
Qingdong Tong
Role: primary
Guoqiang Zhang
Role: primary
Cunliang Deng
Role: primary
Chunhui Zhu
Role: primary
Hongyi Chen
Role: primary
Xiaoping Wu
Role: primary
Other Identifiers
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KY-2025-2-31-2
Identifier Type: -
Identifier Source: org_study_id
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