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A Real-World Study of Antiviral Therapy in Children With Chronic Hepatitis B
Sponsor: Beijing 302 Hospital
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.
Official title: A Multicenter, Prospective, Real-World Study of Antiviral Therapy in Children With Chronic Hepatitis B
Key Details
Gender
All
Age Range
1 Year - 13 Years
Study Type
OBSERVATIONAL
Enrollment
2000
Start Date
2025-05-01
Completion Date
2028-12-31
Last Updated
2025-04-29
Healthy Volunteers
No
Conditions
Interventions
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)
Locations (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