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

November 13, 2025 updated by: Nanfang Hospital, Southern Medical University

Prospective Cohort Study on Pegylated Interferon Alfa-2b in Improving Clinical Cure Rate of Adolescent and Pediatric Patients With Chronic Hepatitis B Virus Infection

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This study is a prospective, multicenter study. A total of 113 subjects (adolescent and pediatric patients with chronic hepatitis B virus [HBV] infection) were recruited and divided into a treatment group and an observation group. After collecting baseline data from both groups, the treatment group was administered pegylated interferon alfa-2b, while the observation group received no drug treatment or was treated with nucleos(t)ide analogs. Blood samples were collected at different follow-up time points to detect relevant indicators. By comparing the baseline data with follow-up data during treatment, indicators such as HBV DNA negativity rate, HBeAg seroconversion rate, and HBsAg clearance rate were observed in adolescent and pediatric patients with chronic HBV infection. This was done to evaluate whether pegylated interferon alfa-2b treatment improves the clinical cure rate in this patient population and to explore optimized antiviral treatment regimens for adolescent and pediatric patients with chronic HBV infection. Additionally, the immune response characteristics were compared between adolescent and pediatric patients with chronic HBV infection who achieved functional cure after pegylated interferon alfa-2b treatment and those who did not. This comparison aimed to investigate the immune mechanism underlying functional cure achieved by pegylated interferon alfa-2b in adolescent and pediatric patients with chronic HBV infection, as well as to identify plasma markers associated with treatment efficacy for predicting therapeutic outcomes.

Study Type

Interventional

Enrollment (Estimated)

113

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510515

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Aged 3 years and above but under 18 years;
  • Positive for hepatitis B virus (HBV) DNA;
  • Positive for hepatitis B surface antigen (HBsAg) (above the lower limit of baseline detection or > 0.05 IU/ml);
  • The subject and their guardian(s) understand the study and voluntarily sign the informed consent form (if the guardians are the subject's parents, both parents must sign jointly).

Exclusion Criteria:

  • Co-infection with hepatitis A virus (HAV), hepatitis C virus (HCV), hepatitis D virus (HDV), hepatitis E virus (HEV), or human immunodeficiency virus (HIV);

  • Having contraindications to pegylated interferon alfa-2b:

    1. Decompensated hepatitis B cirrhosis;
    2. Subjects with autoimmune liver disease, metabolic liver disease, alcoholic liver disease, malignant tumor, decompensated liver disease, or a history of organ transplantation;
    3. Subjects with severe neurological or psychiatric diseases;
    4. Subjects with severe thyroid dysfunction, antinuclear antibody hyperactivity, or other autoimmune diseases;
    5. Subjects with diabetes mellitus with poor blood glucose control;
    6. Subjects with retinal or fundus lesions;
    7. Subjects with severe heart disease, coronary heart disease, or cerebrovascular disease;
    8. Subjects with poorly controlled epilepsy;
  • Adolescent and pediatric subjects with severe renal dysfunction (e.g., creatinine > 1.5 × upper limit of normal [ULN]);
  • Subjects deemed unsuitable for enrollment by the investigator(s).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Drug: Peginterferon alfa-2b Injection
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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

Subjects in the treatment group will receive PEG-IFN-α-2b (Pegylated Interferon-α-2b) treatment for a consecutive 48 weeks. Follow-up visits will be conducted during the treatment period (Weeks 4, 8, 12, 24, 36, and 48) and after treatment completion (Weeks 12 and 24 post-discontinuation), with the total number of injections not exceeding 96.

The efficacy of the treatment for subjects will be mainly evaluated based on the detection results of HBV serological markers (HBsAg、HBsAb、HBeAg、HBeAb、HBcAb) and HBV DNA at time points including baseline, during follow-up, and at the follow-up endpoint.
From enrollment to week 24 post-treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanfang Hospital, Southern Medical University

Investigators

  • Principal Investigator: Yongyin Li, doctor, Nanfang Hospital, Southern Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2026

Primary Completion (Estimated)

August 8, 2028

Study Completion (Estimated)

October 1, 2028

Study Registration Dates

First Submitted

September 18, 2025

First Submitted That Met QC Criteria

November 13, 2025

First Posted (Actual)

November 17, 2025

Study Record Updates

Last Update Posted (Actual)

November 17, 2025

Last Update Submitted That Met QC Criteria

November 13, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NFEC-2025-346

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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