A Real-World Study of Antiviral Therapy in Children With Chronic Hepatitis B
- Conditions
- HBVChronic Hepatitis b
- Interventions
- Drug: Nucleos(t)ide AnaloguesDrug: NAs combined with IFNαOther: drug withdrawal observationOther: comparative observation
- Registration Number
- NCT06926647
- Lead Sponsor
- Beijing 302 Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 2000
-
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.
- 1.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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Initial Treatment Cohort 1 Nucleos(t)ide Analogues - Initial Treatment Cohort 1 Interferon alfa - Initial Treatment Cohort 1 NAs combined with IFNα - Initial Treatment Cohort 1 comparative observation - Previously Treated Cohort 1 Nucleos(t)ide Analogues - Previously Treated Cohort 1 NAs combined with IFNα - Previously Treated Cohort 1 drug withdrawal observation -
- Primary Outcome Measures
Name Time Method HBsAg seroconversion rate Week 48,96
- Secondary Outcome Measures
Name Time Method 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
Related Research Topics
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Trial Locations
- Locations (83)
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
Ankang Central Hospital
🇨🇳Ankang, China
Anyang Fifth People's Hospital
🇨🇳Anyang, China
Beihai People's Hospital
🇨🇳Beihai, China
301 Hospital
🇨🇳Beijing, 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
🇨🇳Shijiazhuang, 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
Xiamen Traditional Chinese Medicine Hospital
🇨🇳Xiamen, 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
Shijiazhuang Fifth Hospital
🇨🇳Shijiazhuang, China
Suzhou Fifth People's Hospital
🇨🇳Suzhou, China
Taian Central Hospital
🇨🇳Tai'an, China
Shanxi Bethune Hospital
🇨🇳Taiyuan, China
Taiyuan Third People's Hospital
🇨🇳Taiyuan, 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
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
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
The First Affiliated Hospital of Xinjiang Medical University
🇨🇳Ürümqi, China
Xinjiang Uygur Autonomous Region Infectious Diseases Hospital
🇨🇳Ürümqi, China