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Starting soon Observational

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

NCT06926647 · tracked via the Priya Life Science China tracker
Phase
Observational
Started
2025-05-01
Last updated
2025-04-29

Condition(s) studied

HBVChronic Hepatitis b

Investigational drug(s) / intervention(s)

Nucleos(t)ide AnaloguesInterferon alfaNAs combined with IFNα →comparative observationdrug withdrawal observation

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

Sex
ALL
Min age
1 Year
Max age
13 Years
Healthy volunteers
No
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 outcome measure(s)

  • HBsAg seroconversion rate — Week 48,96

Trial sites (85)

FacilityCityRegionStatus
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.

Official registry record

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