Hepatitis B Virus InfectionPhase 4NCT07345624
Entecavir With or Without Pegylated Interferon α-2b in Children Aged 3-6 Years With Immune-Tolerant Chronic Hepatitis B
A Phase 4 study testing Entecavir and Entecavir + Pegylated interferon α-2b in people with Hepatitis B Virus Infection and Children, run by Qing-Lei Zeng.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 6 years
- Conditions the study is for
- Hepatitis B Virus Infection, Children, Chronic Hepatitis B
- What is being tested?
- Entecavir and Entecavir + Pegylated interferon α-2b
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 11 Jan 2026to 31 Dec 2030
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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
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.
Read the detailed description
This is a multicenter, open-label, randomized controlled, phase 4 trial enrolling 3-6-year-old children with immune-tolerant HBeAg-positive chronic HBV infection. Participants will be randomly assigned in a 1:1 ratio to two treatment arms, both lasting 96 weeks. The ETV group will receive entecavir (ETV) monotherapy throughout the 96-week treatment course (ETV group). The pegylated interferon (Peg-IFN) group will receive ETV for the first 48 weeks, followed by combination therapy with Peg-IFN α-2b for the remaining 48 weeks (ETV plus IFN combination group). The primary endpoint is the functional cure rate at 24 weeks after treatment discontinuation (week 120). The main secondary endpoints include the rates of undetectable HBV DNA, HBeAg loss, and HBsAg loss at week 24, 48, 72, 96, and 120, and rates of alanine aminotransferase elevation or flares (>5 times of upper limit of normal) and incidence of adverse events at any time during the study. The study will also explore associations between functional cure and baseline or on-treatment parameters. A total of 80 children (40 per group) is required to detect a statistically significant difference between two treatment arms.
- Conditions
- Hepatitis B Virus Infection, Children, Chronic Hepatitis B
- Being tested
- Entecavir, Entecavir + Pegylated interferon α-2b
- Keywords
- Children, Efficacy, Safety, Chronic, Pegylated interferon α-2b, Hepatitis B virus, Entecavir, Functional cure, Immune-tolerant
- Medical subject headings
- Hepatitis B, Hepatitis B, Chronic, Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EntecavirDrug
Also called Runzhong®
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.
Entecavir + Pegylated interferon α-2bDrug
Also called Runzhong®, PEGBING®
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.
| Study group | Role | What they receive |
|---|---|---|
| Entecavir | Experimental | Receive entecavir monotherapy throughout the 96-week treatment course. Receives: 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. Receives: Drug: Entecavir + Pegylated interferon α-2b |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At 24 weeks after treatment cessation.
Secondary outcomes (8)
The rate of HBV DNA undetectable
Proportion of participants with HBV DNA undetectable, defined as HBV DNA <10 IU/mL.
Measured: At week 24, 48, 72, 96, 120 of the study.
The rate of HBeAg loss
Proportion of participants with HBeAg loss, defined as HBeAg <0.18 PEIU/mL.
Measured: At week 24, 48, 72, 96, 120 of the study.
The rate of HBsAg loss
Proportion of participants with HBsAg loss, defined as HBsAg <0.05 IU/mL.
Measured: At week 24, 48, 72, 96, 120 of the study.
The rate of alanine aminotransferase elevation or flare
Proportion of participants with alanine aminotransferase elevation (> 1 time the upper limit of normal, i.e., >40 U/L) or flare rate, defined as ALT >5 times the upper limit of normal, i.e., >200 U/L.
Measured: 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
Proportion of participants with cytopenia, defined as an absolute neutrophil count <1.0×10⁹/L and/or a platelet count <100×10⁹/L.
Measured: At any time during the study, i.e., from the date of patient enrollment through 24 weeks after treatment discontinuation.
The rate of growth suppression
Growth suppression rate, defined as height and weight measurements falling below expected levels based on Chinese national standards and World Health Organization anthropometric z-scores for child growth.
Measured: At week 24, 48, 60, 72, 84, 96, 108, 120 of the study.
The rate of thyroid dysfunction
Proportion of participants with thyroid dysfunction rate, defined as thyroid-stimulating hormone (TSH, normal range 0.27-10 mU/L), free thyroxine (FT4, normal range 10.3-31 pmol/L), or free triiodothyronine (FT3, normal range 3-11.4 pmol/L) levels exceeds the limit of normal or the lower limit of normal .
Measured: At week 72, 96, and 120 of the study.
Any other adverse event
Incidence of other adverse event at any time during study, including but not limited to flu-like symptoms and signs, rash, and other expected or unexpected adverse event.
Measured: At any time during study, i.e., from the date of patient enrollment through 24 weeks after treatment discontinuation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2026
- Study start11 Jan 2026 (estimated)
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis B Virus InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qing-Lei Zeng
- Sponsor type
- University, hospital or other
- Collaborators
- Henan Provincial People's Hospital, Luoyang Central Hospital, Xuchang Central Hospital, Luohe Central Hospital, Yongcheng People's Hospital, Sanmenxia Central Hospital, The Third Affiliated Hospital of Henan Medical University, Weishi County People's Hospital, The Sixth People's Hospital of Zhengzhou, The First Affiliated Hospital of Zhengzhou University, Shangcheng County People's Hospital, The First Affiliated Hospital of Henan Polytechnic University, Nanyang Central Hospital
- Responsible party
- Sponsor-investigator, Qing-Lei Zeng, The First Affiliated Hospital of Zhengzhou University
- Investigators
- Qing-Lei Zeng, M.D., Principal investigator, The First Affiliated Hospital of Zhengzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07345624
- Sponsor's protocol ID
- 2025-KY-1632-001
- Status last verified
- Jan 2026
- First submitted
- 24 Dec 2025
- Last updated
- 16 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07345624
- Acronym / sponsor ID
- 2025-KY-1632-001
- Conditions
- Hepatitis B Virus Infection, Children, Chronic Hepatitis B
- Keywords
- Children, Efficacy, Safety, Chronic, Pegylated interferon α-2b, Hepatitis B virus, Entecavir, Functional cure
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Qing-Lei ZengUniversity, hospital or other
- Collaborators
- Henan Provincial People's Hospital, Luoyang Central Hospital, Xuchang Central Hospital, Luohe Central Hospital, Yongcheng People's Hospital, Sanmenxia Central Hospital, The Third Affiliated Hospital of Henan Medical University, Weishi County People's Hospital, The Sixth People's Hospital of Zhengzhou, The First Affiliated Hospital of Zhengzhou University, Shangcheng County People's Hospital, The First Affiliated Hospital of Henan Polytechnic University, Nanyang Central Hospital
- Study start
- 11 Jan 2026 (estimated)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 16 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a multicenter, open-label, randomized controlled, phase 4 trial enrolling 3-6-year-old children with immune-tolerant HBeAg-positive chronic HBV infection. Participants will be randomly assigned in a 1:1 ratio to two treatment arms, both lasting 96 weeks. The ETV group will receive entecavir (ETV) monotherapy throughout the 96-week treatment course (ETV group). The pegylated interferon (Peg-IFN) group will receive ETV for the first 48 weeks, followed by combination therapy with Peg-IFN α-2b for the remaining 48 weeks (ETV plus IFN combination group). The primary endpoint is the functional cure rate at 24 weeks after treatment discontinuation (week 120). The main secondary endpoints include the rates of undetectable HBV DNA, HBeAg loss, and HBsAg loss at week 24, 48, 72, 96, and 120, and rates of alanine aminotransferase elevation or flares (>5 times of upper limit of normal) and incidence of adverse events at any time during the study. The study will also explore associations between functional cure and baseline or on-treatment parameters. A total of 80 children (40 per group) is required to detect a statistically significant difference between two treatment arms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Entecavir | Experimental | Drug: EntecavirReceive entecavir monotherapy throughout the 96-week treatment course. |
| Entecavir plus Peg-IFN α-2b | Experimental | Drug: Entecavir + Pegylated interferon α-2bReceive entecavir for the first 48 weeks, followed by combination therapy with pegylated interferon α-2b for the remaining 48 weeks. |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (11 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EntecavirAlso: Runzhong®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. | Drug | Entecavir |
| Entecavir + Pegylated interferon α-2bAlso: Runzhong®, PEGBING®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. | Drug | Entecavir plus Peg-IFN α-2b |
Primary outcome
The rate of functional cure
Time frame: At 24 weeks after treatment cessation.
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.
8 secondary outcomes
The rate of HBV DNA undetectable
Time frame: At week 24, 48, 72, 96, 120 of the study.
The rate of HBeAg loss
Time frame: At week 24, 48, 72, 96, 120 of the study.
The rate of HBsAg loss
Time frame: At week 24, 48, 72, 96, 120 of the study.
The rate of alanine aminotransferase elevation or flare
Time frame: 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
Time frame: At any time during the study, i.e., from the date of patient enrollment through 24 weeks after treatment discontinuation.
The rate of growth suppression
Time frame: At week 24, 48, 60, 72, 84, 96, 108, 120 of the study.
The rate of thyroid dysfunction
Time frame: At week 72, 96, and 120 of the study.
Any other adverse event
Time frame: At any time during study, i.e., from the date of patient enrollment through 24 weeks after treatment discontinuation.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Qing-Lei Zeng, M.D. principal investigator
The First Affiliated Hospital of Zhengzhou University
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Entecavir and Entecavir + Pegylated interferon α-2b in people with Hepatitis B Virus Infection and Children, run by Qing-Lei Zeng.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Qing-Lei Zeng, M.D. (86 15838120512, zengqinglei2009@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of functional cure (time frame: At 24 weeks after treatment cessation.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2026.