Prospective Cohort Study on PEG-IFN-α-2b in Improving Clinical Cure Rate of Pediatric Patients With Chronic Hepatitis B

Conditions

• Chronic Hepatitis B Virus
• HBV

Eligibility Criteria

Sex

ALL

Age

3 Years - 18 Years

Healthy Volunteers

Not accepted

Interventions

• Peginterferon alfa-2b Injection — DRUG
  Subjects in the treatment group will receive pegylated interferon alfa-2b treatment. The dosage will be determined based on height and weight, calculated as 180 μg × body surface area / 1.73 m². The administration method is subcutaneous injection once per week for 48 consecutive weeks. Follow-up visits will be conducted during the treatment period (at Week 4, Week 8, Week 12, Week 24, Week 36, and Week 48) and after the end of treatment (at Week 12 post-treatment and Week 24 post-treatment). The total number of injections administered will not exceed 96.

Study Details

In this study, comparisons will be made between the treatment group (which will receive pegylated interferon alfa-2b treatment) and the observation group (which will receive no drug treatment or be treated with nucleos(t)ide analogs). The primary objectives are to address the following questions: compare the efficacy evaluation indicators (with clinical cure rate as the primary one) between the pegylated interferon alfa-2b treatment group and the observation group; assess whether pegylated interferon alfa-2b treatment improves the clinical cure rate in patients with chronic hepatitis B virus (HBV) infection aged 3 years and above but under 18 years (adolescents and children); and explore optimized antiviral treatment regimens for adolescents and children with chronic HBV infection. The secondary objectives are to address the following questions: compare the immune response characteristics between adolescents and children with chronic HBV infection who achieved functional cure after pegylated interferon alfa-2b treatment and those who did not; investigate the immune mechanism underlying the achievement of functional cure in adolescents and children with chronic HBV infection treated with pegylated interferon alfa-2b; and identify plasma markers associated with treatment efficacy for predicting therapeutic outcomes.

Key Dates

Start date

Jan 1, 2026

Status verified

Nov 2025

Primary completion

Aug 8, 2028

Completion

Oct 1, 2028

Study Design

Enrollment

113 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Treatment Group (Pegylated Interferon Alfa-2b)
  Subjects in the treatment group will receive pegylated interferon alfa-2b treatment. The dosage will be determined based on height and weight, calculated as 180 μg × body surface area / 1.73 m². The administration method is subcutaneous injection once per week for 48 consecutive weeks. Follow-up visits will be conducted during the treatment period (at Week 4, Week 8, Week 12, Week 24, Week 36, and Week 48) and after the end of treatment (at Week 12 post-treatment and Week 24 post-treatment). The total number of injections administered will not exceed 96.
• No Intervention: Observation Group
  Subjects in the observation group will receive no drug treatment or be treated with nucleos(t)ide analogs, and will undergo regular follow-up at the specified time points (Week 12, Week 24, Week 48, Week 60, and Week 72).

Primary Outcome Measure

The efficacy of patients treated with PEG-IFN-α-2b (Pegylated Interferon-α-2b) is evaluated based on HBV serological markers and HBV DNA at baseline, during follow-up, and at the follow-up endpoint. [ Time Frame: From enrollment to week 24 post-treatment ]

Central Contacts

• Yongyin Li
  +8613826039505
  [email protected]