A Real-World Study of Antiviral Therapy in Children With Chronic Hepatitis B
Condition(s) studied
Investigational drug(s) / intervention(s)
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.
Interferon alfa: 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: Receive NAs combined with IFNα treatment for 48 weeks.
comparative observation: Blank control observation for 48 weeks.
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)
Study 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
Primary outcome measure(s)
- HBsAg seroconversion rate — Week 48,96
Trial sites (85)
| Facility | City | Region | Status |
|---|---|---|---|
| Ankang Central Hospital | Ankang | China | |
| 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 |
+ 45 more sites — see the full list on the official registry below.
More Beijing 302 Hospital trials in China
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06926647 on ClinicalTrials.gov ↗ ← All trials in China