NCT07345624Not yet recruitingPhase 4
Entecavir With or Without Pegylated Interferon α-2b in Children Aged 3-6 Years With Immune-Tolerant Chronic Hepatitis B
Efficacy and Safety of Entecavir With or Without Pegylated Interferon α-2b in Children Aged 3 to 6 Years With Immune-Tolerant Chronic Hepatitis B Virus Infection (B-Young-Cure-1): A Multicenter, Open-Label, Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 16 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 80 (estimated)
- First submitted
- 24 Dec 2025
- Start date
- 11 Jan 2026
- Primary completion date
- 31 Dec 2030
- Lead sponsor
- Qing-Lei Zeng
- Diseases
- Hepatitis B
- NCT number
- NCT07345624
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 80
- From 11 Jan 2026 to the primary completion date, 31 Dec 2030
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous antiviral treatment for chronic HBV infection;
- Previous or current evidence of hepatocellular carcinoma or cirrhosis;
- 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.
Other illness
- Coinfection with hepatitis C, D, E, human immunodeficiency virus (HIV), Epstein-Barr virus, or cytomegalovirus;
- 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);
Lab values
- 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;
Who the study is looking for
- 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.
Age in the registry: 3 years to 6 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.