NCT07345611

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-active, HBeAg-positive children aged 3-6 years with chronic hepatitis B.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
57mo left

Started Jan 2026

Longer than P75 for phase_4

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress6%
Jan 2026Dec 2030

First Submitted

Initial submission to the registry

December 24, 2025

Completed
18 days until next milestone

Study Start

First participant enrolled

January 11, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 16, 2026

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2030

Last Updated

January 16, 2026

Status Verified

January 1, 2026

Enrollment Period

5 years

First QC Date

December 24, 2025

Last Update Submit

January 7, 2026

Conditions

Hepatitis B Virus InfectionChildrenChronic Hepatitis B

Keywords

ChildrenEfficacyImmune clearanceSafetyChronicEntecavirPegylated interferon α-2bFunctional cureHepatitis B virus

Outcome Measures

Primary Outcomes (1)

  • The rate of functional cure

    Functional cure is defined as the loss of HBsAg to \<0.05 IU/mL and HBeAg clearance, with or without the presence of hepatitis B surface antibody (HBsAb) and hepatitis B e antibody (HBeAb), and undetectable HBV DNA (\<10 IU/mL) at the end of treatment, sustained through 24 weeks post-treatment.

    At 24 weeks after treatment cessation.

Secondary Outcomes (8)

  • The rate of HBV DNA undetectable

    At week 24, 48, 72, 96, 120 of the study.

  • The rate of HBeAg loss

    At week 24, 48, 72, 96, 120 of the study.

  • The rate of HBsAg loss

    At week 24, 48, 72, 96, 120 of the study.

  • The rate of alanine aminotransferase elevation or flare

    At any time during the study, i.e., from the date of patient enrollment through 24 weeks after treatment discontinuation.

  • The rate of cytopenia rate

    At any time during the study, i.e., from the date of patient enrollment through 24 weeks after treatment discontinuation.

  • +3 more secondary outcomes

Study Arms (2)

Entecavir

EXPERIMENTAL

Receive entecavir monotherapy throughout the 96-week treatment course.

Drug: Entecavir

Entecavir plus Peg-IFN α-2b

EXPERIMENTAL

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

Drug: Entecavir + Pegylated interferon α-2b

Interventions

EntecavirDRUG

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.

Also known as: Runzhong®
Entecavir
Entecavir + Pegylated interferon α-2bDRUG

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.

Also known as: Runzhong®, PEGBING®
Entecavir plus Peg-IFN α-2b

Eligibility Criteria

Age3 Years - 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Age between 3 and 6 (more than 3 but less than 7) years;
  • Chronic HBV infection;
  • Positive HBeAg;
  • HBV DNA \>1.0×10⁴ IU/mL;
  • Normal upper abdominal ultrasound without cirrhosis or hepatocellular carcinoma;
  • ALT \>40 U/L.

You may not qualify if:

  • Previous antiviral treatment for chronic HBV infection;
  • Coinfection with hepatitis C, D, E, human immunodeficiency virus (HIV), Epstein-Barr virus, or cytomegalovirus;
  • Previous or current evidence of hepatocellular carcinoma or cirrhosis;
  • Coexistence of any other liver diseases such as autoimmune hepatitis, drug-induced liver injury or Wilson's disease;
  • Coexistence of systemic/other organ disorders (for example with evidence of thyroid disorders);
  • Hemoglobin level \<100 g/L;
  • Absolute neutrophil count \<1.0×10⁹/L.;
  • Platelet count \<125×10⁹/L;
  • Total bilirubin \>1 ULN, i.e., 17.1 μmol/L;
  • Albumin level \<35 g/L;
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hepatitis BHepatitis B, ChronicBronchiolitis Obliterans Syndrome

Interventions

entecavir

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitisLiver DiseasesDigestive System DiseasesHepatitis, ChronicChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsOrganizing PneumoniaBronchiolitis ObliteransBronchiolitisBronchitisBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesGraft vs Host DiseaseImmune System Diseases

Study Officials

  • Qing-Lei Zeng, M.D.

    The First Affiliated Hospital of Zhengzhou University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Qing-Lei Zeng, M.D.

CONTACT

86 15838120512zengqinglei2009@163.com

Zu-Jiang Yu, M.D.

CONTACT

86 186 0371 0022johnyuem@zzu.cn

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Masking Details
None (Open Label)
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 24, 2025

First Posted

January 16, 2026

Study Start

January 11, 2026

Primary Completion (Estimated)

December 31, 2030

Study Completion (Estimated)

December 31, 2030

Last Updated

January 16, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share