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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Initial Treatment Cohort 1 |
| ||
| Previously Treated Cohort 1 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nucleos(t)ide Analogues | Drug | Administer NAs [LAM, ETV, TDF, TAF (TAF preferred for those aged 6 years and older)] continuously for 48 weeks based on age. |
|
| Measure | Description | Time Frame |
|---|---|---|
| HBsAg seroconversion rate | Week 48,96 |
| Measure | Description | Time Frame |
|---|---|---|
| HBV DNA negative conversion rate | Week 48,96 | |
| HBeAg negative conversion rate | Week 48,96 | |
| HBeAg seroconversion rate |
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Inclusion Criteria:
Initial Treatment Group:
Treated Group:
Exclusion Criteria:
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The patients provided by hospitals from various centers across the country are standardized in English translation.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fusheng Wang | Contact | 13601162078 | 13601162078@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Fusheng Wang | Beijing 302 Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ankang Central Hospital | Ankang | China |
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| Interferon alfa | Drug | 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 | Drug | Receive NAs combined with IFNα treatment for 48 weeks. |
|
| comparative observation | Other | Blank control observation for 48 weeks. |
|
| drug withdrawal observation | Other | 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) |
|
| Week 48,96 |
| HBsAg seroconversion rate | Week 48,96 |
| ALT normalization rate | Week 48,96 |
| 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 |
|
| ID | Term |
|---|---|
| D019694 | Hepatitis B, Chronic |
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D016898 | Interferon-alpha |
| ID | Term |
|---|---|
| D007370 | Interferon Type I |
| D007372 | Interferons |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
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