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

NCT07231276 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: NFEC-2025-346
• Study Type: interventional
• Target: 113
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

HBV; Chronic Hepatitis B Virus

Keywords

HBV; chronic hepatitis B virus

Outcome Measures

Primary Outcomes (1)

• 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.

  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

Study Arms (2)

Treatment Group (Pegylated Interferon Alfa-2b)

EXPERIMENTAL

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

Observation Group

NO INTERVENTION

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).

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.

Treatment Group (Pegylated Interferon Alfa-2b)

Eligibility Criteria

• Age: 3 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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:
• Decompensated hepatitis B cirrhosis;
• Subjects with autoimmune liver disease, metabolic liver disease, alcoholic liver disease, malignant tumor, decompensated liver disease, or a history of organ transplantation;
• Subjects with severe neurological or psychiatric diseases;
• Subjects with severe thyroid dysfunction, antinuclear antibody hyperactivity, or other autoimmune diseases;
• Subjects with diabetes mellitus with poor blood glucose control;
• Subjects with retinal or fundus lesions;
• Subjects with severe heart disease, coronary heart disease, or cerebrovascular disease;
• 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).

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead

Study Sites (1)

Nanfang Hospital

Guangzhou, Guangdong, 510515, China

Location

MeSH Terms

Conditions

Hepatitis B, Chronic

Interventions

peginterferon alfa-2b

Condition Hierarchy (Ancestors)

Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Yongyin Li, doctor

  Nanfang Hospital, Southern Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yongyin Li

CONTACT

+8613826039505; yongyinli@foxmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2025
• First Posted: November 17, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): August 8, 2028
• Study Completion (Estimated): October 1, 2028
• Last Updated: November 17, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)