Health TrialsbyHealthPanel

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

ConditionsHBVChronic Hepatitis b
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age1-13
SponsorBeijing 302 Hospital

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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 population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Nucleos(t)ide Analogues

    Drug

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

  • Interferon alfa

    Drug

    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

    Drug

    Receive NAs combined with IFNα treatment for 48 weeks.

  • comparative observation

    Other intervention

    Blank control observation for 48 weeks.

  • drug withdrawal observation

    Other intervention

    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)

Treatment groups

2,000 Participants
are divided into 2 treatment groups
Group A: Initial Treatment Cohort 14 interventions
Group B: Previously Treated Cohort 13 interventions

Trial outcomes

Primary outcomes

1

HBsAg seroconversion rate

Time frame
Week 48,96

Secondary outcomes

1

HBV DNA negative conversion rate

Time frame
Week 48,96
2

HBeAg negative conversion rate

Time frame
Week 48,96
3

HBeAg seroconversion rate

Time frame
Week 48,96
4

HBsAg seroconversion rate

Time frame
Week 48,96

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Beijing 302 Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: