Clinical trial NCT06926647: A Real-World Study of Antiviral Therapy in Children With Chronic Hepatitis B
Official title: A Multicenter, Prospective, Real-World Study of Antiviral Therapy in Children With Chronic Hepatitis B
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: HBV
Chronic Hepatitis b
Keywords: Nucleos(t)ide Analogues（NAs）
Interferon alpha（IFNα）
Lead sponsor: Beijing 302 Hospital
Sponsor class: OTHER
First posted: 2025-04-14
Enrollment: 2000
Sex: ALL
Minimum age (years): 1
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The patients provided by hospitals from various centers across the country are standardized in English translation.

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.


Eligibility criteria: Inclusion Criteria:

* Initial Treatment 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: ≥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.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.

Primary outcomes:
measure: HBsAg seroconversion rate
timeFrame: Week 48,96
Secondary outcomes:
measure: HBV DNA negative conversion rate
timeFrame: Week 48,96
measure: HBeAg negative conversion rate
timeFrame: Week 48,96
measure: HBeAg seroconversion rate
timeFrame: Week 48,96
measure: HBsAg seroconversion rate
timeFrame: Week 48,96
measure: ALT normalization rate
timeFrame: Week 48,96
Other outcomes:
Locations:
city: Ankang
country: China
facility: Ankang Central Hospital
city: Anyang
country: China
facility: Anyang Fifth People's Hospital
city: Beihai
country: China
facility: Beihai People's Hospital
city: Beijing
country: China
facility: 301 Hospital
city: Binzhou
country: China
facility: Binzhou Medical University Affiliated Hospital
city: Changzhi
country: China
facility: Changzhi Medical College Affiliated Peace Hospital
city: Changzhou
country: China
facility: Changzhou Third People's Hospital
city: Chengdu
country: China
facility: Chengdu Public Health Clinical Medical Center
city: Chengdu
country: China
facility: West China Second Hospital, Sichuan University
city: Dalian
country: China
facility: The First Affiliated Hospital of Dalian Medical University
city: Dongguan
country: China
facility: Dongguan People's Hospital
city: Dongying
country: China
facility: Dongying People's Hospital
city: Foshan
country: China
facility: Foshan First People's Hospital
city: Foshan
country: China
facility: Southern Medical University Shunde Hospital
city: Guangzhou
country: China
facility: Guangzhou Medical University Affiliated Women and Children's Medical Center
city: Guangzhou
country: China
facility: The Third Affiliated Hospital of Guangzhou Medical University
city: Guangzhou
country: China
facility: The Third Affiliated Hospital of Sun Yat-sen University
city: Haikou
country: China
facility: Hainan Women and Children's Medical Center
city: Handan
country: China
facility: Handan Infectious Disease Hospital
city: Hefei
country: China
facility: The First Affiliated Hospital of Anhui Medical University
city: Hepu
country: China
facility: Hepu County People's Hospital
city: Heze
country: China
facility: Shanxian Central Hospital
city: Jiangmen
country: China
facility: Jiangmen Traditional Chinese Medicine Hospital
city: Lanzhou
country: China
facility: Lanzhou Second People's Hospital
city: Lhasa
country: China
facility: Tibet Autonomous Region Third People's Hospital
city: Liaocheng
country: China
facility: Liaocheng People's Hospital
city: Linfen
country: China
facility: Linfen People's Hospital
city: Linfen
country: China
facility: Linfen Third People's Hospital
city: Liuzhou
country: China
facility: Liuzhou Workers' Hospital
city: Longyan
country: China
facility: Longyan Second Hospital
city: Luoyang
country: China
facility: Luoyang Central Hospital
city: Luzhou
country: China
facility: Southwest Medical University Affiliated Hospital
city: Nanchang
country: China
facility: Jiangxi Children's Hospital
city: Nanchang
country: China
facility: Nanchang Ninth Hospital
city: Nanchang
country: China
facility: The First Affiliated Hospital of Nanchang University
city: Nanchang
country: China
facility: The Second Affiliated Hospital of Nanchang University
city: Nanning
country: China
facility: Nanning Fourth People's Hospital
city: Nanning
country: China
facility: The First Affiliated Hospital of Guangxi Medical University
city: Nanyang
country: China
facility: Nanyang Central Hospital
city: Putian
country: China
facility: Affiliated Hospital of Putian University
city: Putian
country: China
facility: Putian First Hospital
city: Qingdao
country: China
facility: Qingdao Public Health Clinical Center
city: Quanzhou
country: China
facility: Quanzhou Maternal and Child Health Hospital Children's Hospital
city: Queshan
country: China
facility: Queshan County People's Hospital
city: Shangcheng
country: China
facility: Shangcheng County People's Hospital
city: Shanghai
country: China
facility: Shanghai Children's Hospital
city: Shangqiu
country: China
facility: Shangqiu City Hospital
city: Shangqiu
country: China
facility: Shangqiu First People's Hospital
city: Shangqiu
country: China
facility: Shangqiu Third People's Hospital
city: Shaoguan
country: China
facility: Northern Guangdong Second People's Hospital
city: Shenzhen
country: China
facility: Shenzhen Third People's Hospital
city: Shihezi
country: China
facility: The First Affiliated Hospital of Shihezi University
city: Shijiazhuang
country: China
facility: Handan Infectious Disease Hospital
city: Shijiazhuang
country: China
facility: Shijiazhuang Fifth Hospital
city: Suzhou
country: China
facility: Suzhou Fifth People's Hospital
city: Tai'an
country: China
facility: Taian Central Hospital
city: Taiyuan
country: China
facility: Shanxi Bethune Hospital
city: Taiyuan
country: China
facility: Taiyuan Third People's Hospital
city: Weifang
country: China
facility: Weifang Medical University Affiliated Hospital
city: Weishi
country: China
facility: Weishi County People's Hospital
city: Wuhan
country: China
facility: Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi'an Jiaotong University
city: Xi'an
country: China
facility: The Second Affiliated Hospital of Air Force Medical University (Tangdu Hospital)
city: Xi'an
country: China
facility: The Second Affiliated Hospital of Xi'an Jiaotong University
city: Xiamen
country: China
facility: The First Affiliated Hospital of Xiamen University
city: Xiamen
country: China
facility: Xiamen Traditional Chinese Medicine Hospital
city: Xiamen
country: China
facility: Zhongshan Hospital Affiliated to Xiamen University
city: Xichang
country: China
facility: Liangshan Yi Autonomous Prefecture Seventh People's Hospital
city: Xining
country: China
facility: Qinghai Fourth People's Hospital
city: Xinxiang
country: China
facility: The First Affiliated Hospital of Xinxiang Medical University
city: Xinxiang
country: China
facility: The Third Affiliated Hospital of Xinxiang Medical University
city: Xixian
country: China
facility: Xixian People's Hospital
city: Xuchang
country: China
facility: Xuchang Central Hospital
city: Xuchang
country: China
facility: Xuchang People's Hospital
city: Yantai
country: China
facility: Yantai Qishan Hospital
city: Yongcheng
country: China
facility: Yongcheng People's Hospital
city: Yulin
country: China
facility: Yulin Traditional Chinese Medicine Hospital
city: Yulin
country: China
facility: Yulin Traditional Chinese Medicine Hospital
city: Yuncheng
country: China
facility: Yuncheng Central Hospital
city: Zhenzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
city: Zhongshan
country: China
facility: Zhongshan Second People's Hospital
city: Zhumadian
country: China
facility: Zhumadian Central Hospital
city: Zibo
country: China
facility: Zibo Infectious Diseases Hospital
city: Ürümqi
country: China
facility: The First Affiliated Hospital of Xinjiang Medical University
city: Ürümqi
country: China
facility: Xinjiang Uygur Autonomous Region Infectious Diseases Hospital
Study officials:
affiliation: Fifth Medical Center of Chinese PLA General Hospital
name: Fusheng Wang
role: STUDY_DIRECTOR
References: