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

Starting soon · Phase 4

Conditions studied: Hepatitis B Virus Infection, Children, Chronic Hepatitis B

In brief

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.

Key facts

Study ID: NCT07345611
Run by: Qing-Lei Zeng
People needed: 60
Starts: 2026-01-11
Expected to finish: 2030-12-31
Last updated by the study team: 2026-01-16

Who can join

Age: 3 and older, up to 6. Sex: any. Healthy volunteers: not accepted.

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.

Full record on ClinicalTrials.gov

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