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HBVNCT06926647

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

An observational study of HBV and Chronic Hepatitis b, run by Beijing 302 Hospital at 85 sites in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record

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Trial 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. Read more about this study

Who is it for?
Ages 1 year to 13 years
Conditions the study is for
HBV, Chronic Hepatitis b
What is being tested?
Nucleos(t)ide Analogues, Interferon alfa and NAs combined with IFNα
How many people
2,000 participants
Where
85 sitesChina
Study dates
1 May 2025to 31 Dec 2028
Phase
Observational

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 year to 13 years
  • All sexes
  • No healthy volunteers
  • Child

Study population: The patients provided by hospitals from various centers across the country are standardized in English translation.

Who may be able to join

  • 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:
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  • 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.

Who cannot join

  • 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.

Trial locations and contacts

85 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Fusheng Wang contact

13601162078

13601162078@163.com

85 sites in 1 country

China85 sites

  • Ankang Central Hospital

    Ankang

    Bing Li

  • Anyang Fifth People's Hospital

    Anyang

    Aiqin Hao

  • Beihai People's Hospital

    Beihai

    Feng Long

  • 301 Hospital

    Beijing

    Yongmei Lin

  • Binzhou Medical University Affiliated Hospital

    Binzhou

    Tonggang Liu

  • Changzhi Medical College Affiliated Peace Hospital

    Changzhi

    Suling Chen

  • Changzhou Third People's Hospital

    Changzhou

    Chunyan Ye

  • Chengdu Public Health Clinical Medical Center

    Chengdu

    Li Zhu

  • West China Second Hospital, Sichuan University

    Chengdu

    Yu Zhu

  • The First Affiliated Hospital of Dalian Medical University

    Dalian

    Ying Zhu

  • Dongguan People's Hospital

    Dongguan

    Songmei He

  • Dongying People's Hospital

    Dongying

    Pengyan Li

  • Foshan First People's Hospital

    Foshan

    Honglian Bai

  • Southern Medical University Shunde Hospital

    Foshan

    Hong Li

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

    Guangzhou

    Yi Xu

  • The Third Affiliated Hospital of Guangzhou Medical University

    Guangzhou

    Xingfei Pan

  • The Third Affiliated Hospital of Sun Yat-sen University

    Guangzhou

    Bingliang Lin

  • Hainan Women and Children's Medical Center

    Haikou

    Daojiong Lin

  • Handan Infectious Disease Hospital

    Handan

    Hongxia Zhou

  • The First Affiliated Hospital of Anhui Medical University

    Hefei

    Yufeng Gao

  • Hepu County People's Hospital

    Hepu

    Lundong Wu

  • Shanxian Central Hospital

    Heze

    Jian Liu

  • Jiangmen Traditional Chinese Medicine Hospital

    Jiangmen

    Gang He

  • Lanzhou Second People's Hospital

    Lanzhou

    Wenjuan Shi

  • Tibet Autonomous Region Third People's Hospital

    Lhasa

    Bayangzhen Bian

  • Liaocheng People's Hospital

    Liaocheng

    Sikui Wang

  • Linfen People's Hospital

    Linfen

    Feng Gao

  • Linfen Third People's Hospital

    Linfen

    Xiufang Du

  • Liuzhou Workers' Hospital

    Liuzhou

    Qian Guo

  • Longyan Second Hospital

    Longyan

    Qingdong Tong

  • Luoyang Central Hospital

    Luoyang

    Guoqiang Zhang

  • Southwest Medical University Affiliated Hospital

    Luzhou

    Cunliang Deng

  • Jiangxi Children's Hospital

    Nanchang

    Chunhui Zhu

  • Nanchang Ninth Hospital

    Nanchang

    Hongyi Chen

  • The First Affiliated Hospital of Nanchang University

    Nanchang

    Xiaoping Wu

  • The Second Affiliated Hospital of Nanchang University

    Nanchang

    Shuilin Sun

  • Nanning Fourth People's Hospital

    Nanning

    Fen Li

  • The First Affiliated Hospital of Guangxi Medical University

    Nanning

    Qingwen Shan

  • Nanyang Central Hospital

    Nanyang

    Yuzhuo Wu

  • Affiliated Hospital of Putian University

    Putian

    Rongxian Qiu

  • Putian First Hospital

    Putian

    Boqi Guo

  • Qingdao Public Health Clinical Center

    Qingdao

    RenDong Wei

  • Quanzhou Maternal and Child Health Hospital Children's Hospital

    Quanzhou

    Junfeng Wu

  • Queshan County People's Hospital

    Queshan

    Ruinian Zhang

  • Shangcheng County People's Hospital

    Shangcheng

    Chuanwen Chen

  • Shanghai Children's Hospital

    Shanghai

  • Shangqiu City Hospital

    Shangqiu

    Wenliang Zhou

  • Shangqiu First People's Hospital

    Shangqiu

    Yaqing Liu

  • Shangqiu Third People's Hospital

    Shangqiu

    Kun Lu

  • Northern Guangdong Second People's Hospital

    Shaoguan

    Zhijiao Xiong

  • Shenzhen Third People's Hospital

    Shenzhen

    Fang Wang

  • The First Affiliated Hospital of Shihezi University

    Shihezi

    Songsong Xie

  • Handan Infectious Disease Hospital

    Shijiazhuang

    Xinli Bai

  • Shijiazhuang Fifth Hospital

    Shijiazhuang

    Bo Li

  • Suzhou Fifth People's Hospital

    Suzhou

    Chuanwu Zhu

  • Taian Central Hospital

    Tai’an

    Yang Feng

  • Shanxi Bethune Hospital

    Taiyuan

    Yan Wang

  • Taiyuan Third People's Hospital

    Taiyuan

    Ying Guo

  • The First Affiliated Hospital of Xinjiang Medical University

    Ürümqi

    Lu Xiaoqing

  • Xinjiang Uygur Autonomous Region Infectious Diseases Hospital

    Ürümqi

    Jiang Maimaiti

  • Weifang Medical University Affiliated Hospital

    Weifang

    Jing Feng

  • Weishi County People's Hospital

    Weishi

    Xiangyang Li

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

    Wuhan

    Sainan Shu

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi'an

    Yingli He

  • The Second Affiliated Hospital of Air Force Medical University (Tangdu Hospital)

    Xi'an

    Wen Tang

  • The Second Affiliated Hospital of Xi'an Jiaotong University

    Xi'an

    Shuangsuo Dang

  • The First Affiliated Hospital of Xiamen University

    Xiamen

    Xiulan Xue

  • Xiamen Traditional Chinese Medicine Hospital

    Xiamen

    Qingfa Luan

  • Zhongshan Hospital Affiliated to Xiamen University

    Xiamen

    Ling Chen

  • Liangshan Yi Autonomous Prefecture Seventh People's Hospital

    Xichang

    Min Fang

  • Qinghai Fourth People's Hospital

    Xining

    Haifang Cao

  • The First Affiliated Hospital of Xinxiang Medical University

    Xinxiang

    Daokun Yang

  • The Third Affiliated Hospital of Xinxiang Medical University

    Xinxiang

    Qian Dou

  • Xixian People's Hospital

    Xixian

    Wenhua Zhai

  • Xuchang Central Hospital

    Xuchang

    Weihong Li

  • Xuchang People's Hospital

    Xuchang

    Xia Zhang

  • Yantai Qishan Hospital

    Yantai

    Haifeng Yu

  • Yongcheng People's Hospital

    Yongcheng

    Shengli Ma

  • Yulin Traditional Chinese Medicine Hospital

    Yulin

    Fanrong Liu

  • Yulin Traditional Chinese Medicine Hospital

    Yulin

    Wuhai Tan

  • Yuncheng Central Hospital

    Yuncheng

    Lijun Chang

  • The First Affiliated Hospital of Zhengzhou University

    Zhenzhou

    Hongxia Ran

  • Zhongshan Second People's Hospital

    Zhongshan

    Qianhua Zhang

  • Zhumadian Central Hospital

    Zhumadian

    Guifu Shi

  • Zibo Infectious Diseases Hospital

    Zibo

    Huibin chu

Other trials in China

About this study

Official title: A Multicenter, Prospective, Real-World Study of Antiviral Therapy in Children With Chronic Hepatitis B

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.

Being tested
Nucleos(t)ide Analogues, Interferon alfa, NAs combined with IFNα, comparative observation, drug withdrawal observation
Keywords
Nucleos(t)ide Analogues（NAs）, Interferon alpha（IFNα）
Medical subject headings
Hepatitis B, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nucleos(t)ide AnaloguesDrug

    Administer NAs [LAM, ETV, TDF, TAF (TAF preferred for those aged 6 years and older)] continuously for 48 weeks based on age.

  • Interferon alfaDrug

    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 IFNαDrug

    Receive NAs combined with IFNα treatment for 48 weeks.

  • comparative observationOther

    Blank control observation for 48 weeks.

  • drug withdrawal observationOther

    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)

Study groups in NCT06926647
Study groupRoleWhat they receive
Initial Treatment Cohort 1Not described
Receives: Drug: Nucleos(t)ide Analogues; Drug: Interferon alfa; Drug: NAs combined with IFNα; Other: comparative observation
Previously Treated Cohort 1Not described
Receives: Drug: Nucleos(t)ide Analogues; Drug: NAs combined with IFNα; Other: drug withdrawal observation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. HBsAg seroconversion rate

    Measured: Week 48,96

Secondary outcomes (5)

  1. HBV DNA negative conversion rate

    Measured: Week 48,96

  2. HBeAg negative conversion rate

    Measured: Week 48,96

  3. HBeAg seroconversion rate

    Measured: Week 48,96

  4. HBsAg seroconversion rate

    Measured: Week 48,96

  5. ALT normalization rate

    Measured: Week 48,96

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Apr 2025
  2. Study start1 May 2025 (estimated)
  3. Primary completion15 Dec 2028 (estimated)
  4. Study completion31 Dec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
2,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06926647
Sponsor's protocol ID
KY-2025-2-31-2
Status last verified
Apr 2025
First submitted
11 Apr 2025
Last updated
29 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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