Not Yet RecruitingPhase 4

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

80 participantsStarted 2026-01-11

Plain-language 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.

Who can participate

Age range3 Years – 6 Years

SexALL

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Inclusion criteria

✓. Aged 3-6 (more than 3 but less than 7) years;
✓. With chronic HBV infection;
✓. HBeAg-positive;
✓. HBV DNA \>1.0×10⁷ IU/mL;
✓. Normal upper abdominal ultrasound;
✓. 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

✕. 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;

What they're measuring

The rate of functional cure

Timeframe: At 24 weeks after treatment cessation.

Trial details

NCT IDNCT07345624

SponsorQing-Lei Zeng

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2030-12-31

Contact for this trial

Qing-Lei Zeng, M.D.

86 15838120512 zengqinglei2009@163.com

View on ClinicalTrials.gov More Hepatitis B Virus Infection trials