drugset / Trial / NCT07345624
Entecavir With or Without Pegylated Interferon α-2b in Children Aged 3-6 Years With Immune-Tolerant Chronic Hepatitis B
Phase 4
Not yet recruiting
80 enrolled
Qing-Lei Zeng
Henan Provincial People's Hospital · collabLuohe Central Hospital · collabLuoyang Central Hospital · collabNanyang Central Hospital · collabSanmenxia Central Hospital · collabShangcheng County People's Hospital · collabThe First Affiliated Hospital of Henan Polytechnic University · collabThe First Affiliated Hospital of Zhengzhou University · collabThe Sixth People's Hospital of Zhengzhou · collabThe Third Affiliated Hospital of Henan Medical University · collabWeishi County People's Hospital · collabXuchang Central Hospital · collabYongcheng People's Hospital · collab
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2026-01-11
- Primary completion
- 2030-12-31
- Completion
- 2030-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Entecavir | Small molecule | 0.015 mg/kg | Oral |
| Subject | Entecavir | Small molecule | 0.5 mg | Oral |
| Subject | Peginterferon alfa-2b | Protein / enzyme biologic | 104 ug/m2 | Subcutaneous |