Entecavir With or Without Pegylated Interferon α-2b in Children Aged 3-6 Years With Immune-Tolerant Chronic Hepatitis B

Summary

This study aims to evaluate the efficacy and safety of entecavir monotherapy versus sequential entecavir plus pegylated interferon α-2b in achieving functional cure in immune-tolerant, HBeAg-positive children aged 3-6 years with chronic hepatitis B virus infection.

Conditions

• Hepatitis B Virus Infection
• Children
• Chronic Hepatitis B

Interventions

DRUG

Entecavir

Receive entecavir onotherapy throughout the 96-week treatment course, the dosage of entecavir is 0.015 mg/kg/day for those weighing between 10 and 30 kg; for those weighing more than 30 kg, the dosage is 0.5 mg/day, oral.

DRUG

Entecavir + Pegylated interferon α-2b

Receive entecavir (with dosing adjusted by body weight: 0.015 mg/kg/day for subjects weighing 10-30 kg, and 0.5 mg/day for those \>30 kg, oral) for the first 48 weeks, followed by combination therapy with pegylated interferon α-2b (104 μg/m², weekly, subcutaneous injection) for the remaining 48 weeks.

Sponsors & Collaborators

• Henan Provincial People's Hospital

  collaborator OTHER

• Luoyang Central Hospital

  collaborator OTHER

• Xuchang Central Hospital

  collaborator UNKNOWN

• Luohe Central Hospital

  collaborator UNKNOWN

• Yongcheng People's Hospital

  collaborator UNKNOWN

• Sanmenxia Central Hospital

  collaborator UNKNOWN

• The Third Affiliated Hospital of Henan Medical University

  collaborator UNKNOWN

• Weishi County People's Hospital

  collaborator UNKNOWN

• The Sixth People's Hospital of Zhengzhou

  collaborator OTHER

• The First Affiliated Hospital of Henan Medical University

  collaborator UNKNOWN

• Shangcheng County People's Hospital

  collaborator UNKNOWN

• The First Affiliated Hospital of Henan Polytechnic University

  collaborator UNKNOWN

• Nanyang Central Hospital

  collaborator OTHER

• Qing-Lei Zeng

  lead OTHER

Principal Investigators

• Qing-Lei Zeng, M.D. · The First Affiliated Hospital of Zhengzhou University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

3 Years

Max Age

6 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-01-11

Primary Completion

2030-12-31

Completion

2030-12-31