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

NCT ID: NCT07345624

Last Updated: 2026-01-16

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-11
• Study Completion Date: 2030-12-31

Brief 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.

Detailed Description

This is a multicenter, open-label, randomized controlled, phase 4 trial enrolling 3-6-year-old children with immune-tolerant HBeAg-positive chronic HBV infection. Participants will be randomly assigned in a 1:1 ratio to two treatment arms, both lasting 96 weeks. The ETV group will receive entecavir (ETV) monotherapy throughout the 96-week treatment course (ETV group). The pegylated interferon (Peg-IFN) group will receive ETV for the first 48 weeks, followed by combination therapy with Peg-IFN α-2b for the remaining 48 weeks (ETV plus IFN combination group). The primary endpoint is the functional cure rate at 24 weeks after treatment discontinuation (week 120). The main secondary endpoints include the rates of undetectable HBV DNA, HBeAg loss, and HBsAg loss at week 24, 48, 72, 96, and 120, and rates of alanine aminotransferase elevation or flares (>5 times of upper limit of normal) and incidence of adverse events at any time during the study. The study will also explore associations between functional cure and baseline or on-treatment parameters. A total of 80 children (40 per group) is required to detect a statistically significant difference between two treatment arms.

Conditions

Hepatitis B Virus Infection; Children; Chronic Hepatitis B

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Entecavir

Receive entecavir monotherapy throughout the 96-week treatment course.

Group Type: EXPERIMENTAL

Entecavir

Intervention Type: DRUG

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.

Entecavir plus Peg-IFN α-2b

Receive entecavir for the first 48 weeks, followed by combination therapy with pegylated interferon α-2b for the remaining 48 weeks.

Group Type: EXPERIMENTAL

Entecavir + Pegylated interferon α-2b

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Runzhong®; Runzhong®; PEGBING®

Eligibility Criteria

Inclusion Criteria

1. Aged 3-6 (more than 3 but less than 7) years;

2. With chronic HBV infection;

3. HBeAg-positive;

4. HBV DNA >1.0×10⁷ IU/mL;

5. Normal upper abdominal ultrasound;

6. ALT <40 U/L, HBsAg positivity, HBeAg positivity, and HBV DNA>1.0×10⁷IU/mL for at least two times, with an interval of 6 months or more.

Exclusion Criteria

1. Previous antiviral treatment for chronic HBV infection;

2. Coinfection with hepatitis C, D, E, human immunodeficiency virus (HIV), Epstein-Barr virus, or cytomegalovirus;

3. Previous or current evidence of hepatocellular carcinoma or cirrhosis;

4. Coexistence of any other liver diseases such as autoimmune hepatitis, drug-induced liver injury or Wilson's disease;

5. Coexistence of systemic/other organ disorders (for example with evidence of thyroid disorders);

6. Hemoglobin level <100 g/L.

7. Absolute neutrophil count <1.0×10⁹/L;

8. Platelet count <125×10⁹/L;

9. Total bilirubin >1 ULN, i.e., 17.1 μmol/L;

10. Albumin level <35 g/L;

11. Concurrent treatment with other drugs, including but not limited to nephrotoxic drugs, immune modulators, cytotoxic drugs, Chinese traditional medicine or supplements, nonsteroidal anti-inflammatory drugs, or steroids.

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Henan Provincial People's Hospital

OTHER

Sponsor Role: collaborator

Luoyang Central Hospital

OTHER

Sponsor Role: collaborator

Xuchang Central Hospital

UNKNOWN

Sponsor Role: collaborator

Luohe Central Hospital

UNKNOWN

Sponsor Role: collaborator

Yongcheng People's Hospital

UNKNOWN

Sponsor Role: collaborator

Sanmenxia Central Hospital

UNKNOWN

Sponsor Role: collaborator

The Third Affiliated Hospital of Henan Medical University

UNKNOWN

Sponsor Role: collaborator

Weishi County People's Hospital

UNKNOWN

Sponsor Role: collaborator

The Sixth People's Hospital of Zhengzhou

OTHER

Sponsor Role: collaborator

The First Affiliated Hospital of Henan Medical University

UNKNOWN

Sponsor Role: collaborator

Shangcheng County People's Hospital

UNKNOWN

Sponsor Role: collaborator

The First Affiliated Hospital of Henan Polytechnic University

UNKNOWN

Sponsor Role: collaborator

Nanyang Central Hospital

OTHER

Sponsor Role: collaborator

Qing-Lei Zeng

OTHER

Sponsor Role: lead

Responsible Party

Qing-Lei Zeng

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Qing-Lei Zeng, M.D.

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital of Zhengzhou University

Central Contacts

Qing-Lei Zeng, M.D.

Role: CONTACT

zengqinglei2009@163.com

86 15838120512

Zu-Jiang Yu, M.D.

Role: CONTACT

johnyuem@zzu.cn

86 186 0371 0022

Other Identifiers

2025-KY-1632-001

Identifier Type: -

Identifier Source: org_study_id