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

Not yet recruitingOBSERVATIONAL
Enrollment

2,000

Participants

Timeline

Start Date

May 1, 2025

Primary Completion Date

December 15, 2028

Study Completion Date

December 31, 2028

Conditions
HBVChronic Hepatitis b
Interventions
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.

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)

Trial Locations (85)

Unknown

Ankang Central Hospital, Ankang

Anyang Fifth People's Hospital, Anyang

Beihai People's Hospital, Beihai

301 Hospital, Beijing

Binzhou Medical University Affiliated Hospital, Binzhou

Changzhi Medical College Affiliated Peace Hospital, Changzhi

Changzhou Third People's Hospital, Changzhou

Chengdu Public Health Clinical Medical Center, Chengdu

West China Second Hospital, Sichuan University, Chengdu

The First Affiliated Hospital of Dalian Medical University, Dalian

Dongguan People's Hospital, Dongguan

Dongying People's Hospital, Dongying

Foshan First People's Hospital, Foshan

Southern Medical University Shunde Hospital, Foshan

Guangzhou Medical University Affiliated Women and Children's Medical Center, Guangzhou

The Third Affiliated Hospital of Guangzhou Medical University, Guangzhou

The Third Affiliated Hospital of Sun Yat-sen University, Guangzhou

Hainan Women and Children's Medical Center, Haikou

Handan Infectious Disease Hospital, Handan

The First Affiliated Hospital of Anhui Medical University, Hefei

Hepu County People's Hospital, Hepu

Shanxian Central Hospital, Heze

Jiangmen Traditional Chinese Medicine Hospital, Jiangmen

Lanzhou Second People's Hospital, Lanzhou

Tibet Autonomous Region Third People's Hospital, Lhasa

Liaocheng People's Hospital, Liaocheng

Linfen People's Hospital, Linfen

Linfen Third People's Hospital, Linfen

Liuzhou Workers' Hospital, Liuzhou

Longyan Second Hospital, Longyan

Luoyang Central Hospital, Luoyang

Southwest Medical University Affiliated Hospital, Luzhou

Jiangxi Children's Hospital, Nanchang

Nanchang Ninth Hospital, Nanchang

The First Affiliated Hospital of Nanchang University, Nanchang

The Second Affiliated Hospital of Nanchang University, Nanchang

Nanning Fourth People's Hospital, Nanning

The First Affiliated Hospital of Guangxi Medical University, Nanning

Nanyang Central Hospital, Nanyang

Affiliated Hospital of Putian University, Putian

Putian First Hospital, Putian

Qingdao Public Health Clinical Center, Qingdao

Quanzhou Maternal and Child Health Hospital Children's Hospital, Quanzhou

Queshan County People's Hospital, Queshan

Shangcheng County People's Hospital, Shangcheng

Shanghai Children's Hospital, Shanghai

Shangqiu City Hospital, Shangqiu

Shangqiu First People's Hospital, Shangqiu

Shangqiu Third People's Hospital, Shangqiu

Northern Guangdong Second People's Hospital, Shaoguan

Shenzhen Third People's Hospital, Shenzhen

The First Affiliated Hospital of Shihezi University, Shihezi

Handan Infectious Disease Hospital, Shijiazhuang

Shijiazhuang Fifth Hospital, Shijiazhuang

Suzhou Fifth People's Hospital, Suzhou

Shanxi Bethune Hospital, Taiyuan

Taiyuan Third People's Hospital, Taiyuan

Taian Central Hospital, Tai’an

The First Affiliated Hospital of Xinjiang Medical University, Ürümqi

Xinjiang Uygur Autonomous Region Infectious Diseases Hospital, Ürümqi

Weifang Medical University Affiliated Hospital, Weifang

Weishi County People's Hospital, Weishi

Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology, Wuhan

The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an

The Second Affiliated Hospital of Air Force Medical University (Tangdu Hospital), Xi'an

The Second Affiliated Hospital of Xi'an Jiaotong University, Xi'an

The First Affiliated Hospital of Xiamen University, Xiamen

Xiamen Traditional Chinese Medicine Hospital, Xiamen

Zhongshan Hospital Affiliated to Xiamen University, Xiamen

Liangshan Yi Autonomous Prefecture Seventh People's Hospital, Xichang

Qinghai Fourth People's Hospital, Xining

The First Affiliated Hospital of Xinxiang Medical University, Xinxiang

The Third Affiliated Hospital of Xinxiang Medical University, Xinxiang

Xixian People's Hospital, Xixian

Xuchang Central Hospital, Xuchang

Xuchang People's Hospital, Xuchang

Yantai Qishan Hospital, Yantai

Yongcheng People's Hospital, Yongcheng

Yulin Traditional Chinese Medicine Hospital, Yulin

Yulin Traditional Chinese Medicine Hospital, Yulin

Yuncheng Central Hospital, Yuncheng

The First Affiliated Hospital of Zhengzhou University, Zhenzhou

Zhongshan Second People's Hospital, Zhongshan

Zhumadian Central Hospital, Zhumadian

Zibo Infectious Diseases Hospital, Zibo

All Listed Sponsors
lead

Beijing 302 Hospital

OTHER

NCT06926647 - A Real-World Study of Antiviral Therapy in Children With Chronic Hepatitis B | Biotech Hunter | Biotech Hunter