Not yet recruiting NCT06926647
A Real-World Study of Antiviral Therapy in Children With Chronic Hepatitis B
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Nucleos(t)ide Analogues, Interferon alfa, NAs combined with IFNα, comparative observation.
- Who it may be relevant to
- Registry conditions: HBV, Chronic Hepatitis b. Basic parameters: 1 year — 13 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Multicenter, Prospective, Real-World Study of Antiviral Therapy in Children With Chronic Hepatitis B
Overview
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.
Interventions
- Drug 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. - Drug Interferon alfa
IFNα monotherapy for 48 weeks (select conventional IFNα for ages ≥1 and \<3 years, select PEG-IFNα-2b for ages ≥3 years) - Drug NAs combined with IFNα
Receive NAs combined with IFNα treatment for 48 weeks. - Other comparative observation
Blank control observation for 48 weeks. - Other 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)
Primary outcome measures
- HBsAg seroconversion rate [Time frame: Week 48,96]
Secondary outcome measures (5)
- HBV DNA negative conversion rate [Time frame: Week 48,96]
- HBeAg negative conversion rate [Time frame: Week 48,96]
- HBeAg seroconversion rate [Time frame: Week 48,96]
- HBsAg seroconversion rate [Time frame: Week 48,96]
- ALT normalization rate [Time frame: Week 48,96]
Eligibility criteria
Inclusion criteria
- 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.
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 85 centers
- Ankang Central Hospital — Ankang
- Anyang Fifth People's Hospital — Anyang
- Beihai People's Hospital — Beihai
- 301 Hospital — Beijing
- Binzhou Medical University Affiliated Hospital — Binzhou
- Changzhi Medical College Affiliated Peace Hospital — Changzhi
- Changzhou Third People's Hospital — Changzhou
- Chengdu Public Health Clinical Medical Center — Chengdu
- … and 77 more centers
Identifiers
NCT: NCT06926647 · KY-2025-2-31-2