HBVPhase 4NCT07231276
Prospective Cohort Study on PEG-IFN-α-2b in Improving Clinical Cure Rate of Pediatric Patients With Chronic Hepatitis B
A Phase 4 study testing Peginterferon alfa-2b Injection in people with HBV and Chronic Hepatitis B Virus, run by Nanfang Hospital, Southern Medical University at 1 site in China.
Trial summary
In this study, comparisons will be made between the treatment group (which will receive pegylated interferon alfa-2b treatment) and the observation group (which will receive no drug treatment or be treated with nucleos(t)ide analogs). Read more about this study
- Who is it for?
- Ages 3 to 18 years
- Conditions the study is for
- HBV, Chronic Hepatitis B Virus
- What is being tested?
- Peginterferon alfa-2b Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 113 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2026to 1 Oct 2028
- 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 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Aged 3 years and above but under 18 years;
- Positive for hepatitis B virus (HBV) DNA;
- Positive for hepatitis B surface antigen (HBsAg) (above the lower limit of baseline detection or > 0.05 IU/ml);
- The subject and their guardian(s) understand the study and voluntarily sign the informed consent form (if the guardians are the subject's parents, both parents must sign jointly).
Who cannot join
- Co-infection with hepatitis A virus (HAV), hepatitis C virus (HCV), hepatitis D virus (HDV), hepatitis E virus (HEV), or human immunodeficiency virus (HIV);
- Having contraindications to pegylated interferon alfa-2b:
- Decompensated hepatitis B cirrhosis;
- Subjects with autoimmune liver disease, metabolic liver disease, alcoholic liver disease, malignant tumor, decompensated liver disease, or a history of organ transplantation;
- Subjects with severe neurological or psychiatric diseases;
- Subjects with severe thyroid dysfunction, antinuclear antibody hyperactivity, or other autoimmune diseases;
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- Subjects with diabetes mellitus with poor blood glucose control;
- Subjects with retinal or fundus lesions;
- Subjects with severe heart disease, coronary heart disease, or cerebrovascular disease;
- Subjects with poorly controlled epilepsy;
- Adolescent and pediatric subjects with severe renal dysfunction (e.g., creatinine > 1.5 × upper limit of normal [ULN]);
- Subjects deemed unsuitable for enrollment by the investigator(s).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Nanfang Hospital
Guangzhou, Guangdong, 510515
Yongyin Li, doctor, +8613826039505, yongyinli@foxmail.com
About this study
Official title: Prospective Cohort Study on Pegylated Interferon Alfa-2b in Improving Clinical Cure Rate of Adolescent and Pediatric Patients With Chronic Hepatitis B Virus Infection
In this study, comparisons will be made between the treatment group (which will receive pegylated interferon alfa-2b treatment) and the observation group (which will receive no drug treatment or be treated with nucleos(t)ide analogs). The primary objectives are to address the following questions: compare the efficacy evaluation indicators (with clinical cure rate as the primary one) between the pegylated interferon alfa-2b treatment group and the observation group; assess whether pegylated interferon alfa-2b treatment improves the clinical cure rate in patients with chronic hepatitis B virus (HBV) infection aged 3 years and above but under 18 years (adolescents and children); and explore optimized antiviral treatment regimens for adolescents and children with chronic HBV infection. The secondary objectives are to address the following questions: compare the immune response characteristics between adolescents and children with chronic HBV infection who achieved functional cure after pegylated interferon alfa-2b treatment and those who did not; investigate the immune mechanism underlying the achievement of functional cure in adolescents and children with chronic HBV infection treated with pegylated interferon alfa-2b; and identify plasma markers associated with treatment efficacy for predicting therapeutic outcomes.
Read the detailed description
This study is a prospective, multicenter study. A total of 113 subjects (adolescent and pediatric patients with chronic hepatitis B virus [HBV] infection) were recruited and divided into a treatment group and an observation group. After collecting baseline data from both groups, the treatment group was administered pegylated interferon alfa-2b, while the observation group received no drug treatment or was treated with nucleos(t)ide analogs. Blood samples were collected at different follow-up time points to detect relevant indicators. By comparing the baseline data with follow-up data during treatment, indicators such as HBV DNA negativity rate, HBeAg seroconversion rate, and HBsAg clearance rate were observed in adolescent and pediatric patients with chronic HBV infection. This was done to evaluate whether pegylated interferon alfa-2b treatment improves the clinical cure rate in this patient population and to explore optimized antiviral treatment regimens for adolescent and pediatric patients with chronic HBV infection. Additionally, the immune response characteristics were compared between adolescent and pediatric patients with chronic HBV infection who achieved functional cure after pegylated interferon alfa-2b treatment and those who did not. This comparison aimed to investigate the immune mechanism underlying functional cure achieved by pegylated interferon alfa-2b in adolescent and pediatric patients with chronic HBV infection, as well as to identify plasma markers associated with treatment efficacy for predicting therapeutic outcomes.
- Conditions
- HBV, Chronic Hepatitis B Virus
- Being tested
- Peginterferon alfa-2b Injection
- Keywords
- HBV, chronic hepatitis B virus
- Medical subject headings
- Hepatitis B, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peginterferon alfa-2b InjectionDrug
Subjects in the treatment group will receive pegylated interferon alfa-2b treatment. The dosage will be determined based on height and weight, calculated as 180 μg × body surface area / 1.73 m². The administration method is subcutaneous injection once per week for 48 consecutive weeks. Follow-up visits will be conducted during the treatment period (at Week 4, Week 8, Week 12, Week 24, Week 36, and Week 48) and after the end of treatment (at Week 12 post-treatment and Week 24 post-treatment). The total number of injections administered will not exceed 96.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group (Pegylated Interferon Alfa-2b) | Experimental | Subjects in the treatment group will receive pegylated interferon alfa-2b treatment. The dosage will be determined based on height and weight, calculated as 180 μg × body surface area / 1.73 m². The administration method is subcutaneous injection once per week for 48 consecutive weeks. Follow-up visits will be conducted during the treatment period (at Week 4, Week 8, Week 12, Week 24, Week 36, and Week 48) and after the end of treatment (at Week 12 post-treatment and Week 24 post-treatment). The total number of injections administered will not exceed 96. Receives: Drug: Peginterferon alfa-2b Injection |
| Observation Group | No intervention | Subjects in the observation group will receive no drug treatment or be treated with nucleos(t)ide analogs, and will undergo regular follow-up at the specified time points (Week 12, Week 24, Week 48, Week 60, and Week 72). |
What is being measured
The primary outcome is the main question the study is designed to answer.
The efficacy of patients treated with PEG-IFN-α-2b (Pegylated Interferon-α-2b) is evaluated based on HBV serological markers and HBV DNA at baseline, during follow-up, and at the follow-up endpoint.
Subjects in the treatment group will receive PEG-IFN-α-2b (Pegylated Interferon-α-2b) treatment for a consecutive 48 weeks. Follow-up visits will be conducted during the treatment period (Weeks 4, 8, 12, 24, 36, and 48) and after treatment completion (Weeks 12 and 24 post-discontinuation), with the total number of injections not exceeding 96.
The efficacy of the treatment for subjects will be mainly evaluated based on the detection results of HBV serological markers (HBsAg、HBsAb、HBeAg、HBeAb、HBcAb) and HBV DNA at time points including baseline, during follow-up, and at the follow-up endpoint.
Measured: From enrollment to week 24 post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2025
- Study start1 Jan 2026 (estimated)
- Primary completion8 Aug 2028 (estimated)
- Study completion1 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HBVStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 113 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yongyin Li, doctor, Principal investigator, Nanfang Hospital, Southern Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07231276
- Sponsor's protocol ID
- NFEC-2025-346
- Status last verified
- Nov 2025
- First submitted
- 18 Sep 2025
- Last updated
- 17 Nov 2025
- 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 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Cohort Study on Pegylated Interferon Alfa-2b in Improving Clinical Cure Rate of Adolescent and Pediatric Patients With Chronic Hepatitis B Virus Infection
- ClinicalTrials.gov ID
- NCT07231276
- Acronym / sponsor ID
- NFEC-2025-346
- Conditions
- HBV, Chronic Hepatitis B Virus
- Keywords
- HBV, chronic hepatitis B virus
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 113 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 8 Aug 2028 (estimated)
- Study completion
- 1 Oct 2028 (estimated)
- First posted
- 17 Nov 2025 (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.
In this study, comparisons will be made between the treatment group (which will receive pegylated interferon alfa-2b treatment) and the observation group (which will receive no drug treatment or be treated with nucleos(t)ide analogs). The primary objectives are to address the following questions: compare the efficacy evaluation indicators (with clinical cure rate as the primary one) between the pegylated interferon alfa-2b treatment group and the observation group; assess whether pegylated interferon alfa-2b treatment improves the clinical cure rate in patients with chronic hepatitis B virus (HBV) infection aged 3 years and above but under 18 years (adolescents and children); and explore optimized antiviral treatment regimens for adolescents and children with chronic HBV infection. The secondary objectives are to address the following questions: compare the immune response characteristics between adolescents and children with chronic HBV infection who achieved functional cure after pegylated interferon alfa-2b treatment and those who did not; investigate the immune mechanism underlying the achievement of functional cure in adolescents and children with chronic HBV infection treated with pegylated interferon alfa-2b; and identify plasma markers associated with treatment efficacy for predicting therapeutic outcomes.
Detailed description
This study is a prospective, multicenter study. A total of 113 subjects (adolescent and pediatric patients with chronic hepatitis B virus [HBV] infection) were recruited and divided into a treatment group and an observation group. After collecting baseline data from both groups, the treatment group was administered pegylated interferon alfa-2b, while the observation group received no drug treatment or was treated with nucleos(t)ide analogs. Blood samples were collected at different follow-up time points to detect relevant indicators. By comparing the baseline data with follow-up data during treatment, indicators such as HBV DNA negativity rate, HBeAg seroconversion rate, and HBsAg clearance rate were observed in adolescent and pediatric patients with chronic HBV infection. This was done to evaluate whether pegylated interferon alfa-2b treatment improves the clinical cure rate in this patient population and to explore optimized antiviral treatment regimens for adolescent and pediatric patients with chronic HBV infection. Additionally, the immune response characteristics were compared between adolescent and pediatric patients with chronic HBV infection who achieved functional cure after pegylated interferon alfa-2b treatment and those who did not. This comparison aimed to investigate the immune mechanism underlying functional cure achieved by pegylated interferon alfa-2b in adolescent and pediatric patients with chronic HBV infection, as well as to identify plasma markers associated with treatment efficacy for predicting therapeutic outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Group (Pegylated Interferon Alfa-2b) | Experimental | Drug: Peginterferon alfa-2b InjectionSubjects in the treatment group will receive pegylated interferon alfa-2b treatment. The dosage will be determined based on height and weight, calculated as 180 μg × body surface area / 1.73 m². The administration method is subcutaneous injection once per week for 48 consecutive weeks. Follow-up visits will be conducted during the treatment period (at Week 4, Week 8, Week 12, Week 24, Week 36, and Week 48) and after the end of treatment (at Week 12 post-treatment and Week 24 post-treatment). The total number of injections administered will not exceed 96. |
| Observation Group | No intervention | –Subjects in the observation group will receive no drug treatment or be treated with nucleos(t)ide analogs, and will undergo regular follow-up at the specified time points (Week 12, Week 24, Week 48, Week 60, and Week 72). |
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Aged 3 years and above but under 18 years;
- Positive for hepatitis B virus (HBV) DNA;
- Positive for hepatitis B surface antigen (HBsAg) (above the lower limit of baseline detection or > 0.05 IU/ml);
- The subject and their guardian(s) understand the study and voluntarily sign the informed consent form (if the guardians are the subject's parents, both parents must sign jointly).
Key exclusion criteria (12 listed)
- Co-infection with hepatitis A virus (HAV), hepatitis C virus (HCV), hepatitis D virus (HDV), hepatitis E virus (HEV), or human immunodeficiency virus (HIV);
- Having contraindications to pegylated interferon alfa-2b:
- Adolescent and pediatric subjects with severe renal dysfunction (e.g., creatinine > 1.5 × upper limit of normal [ULN]);
- Subjects deemed unsuitable for enrollment by the investigator(s).
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 |
|---|---|---|
| Peginterferon alfa-2b InjectionSubjects in the treatment group will receive pegylated interferon alfa-2b treatment. The dosage will be determined based on height and weight, calculated as 180 μg × body surface area / 1.73 m². The administration method is subcutaneous injection once per week for 48 consecutive weeks. Follow-up visits will be conducted during the treatment period (at Week 4, Week 8, Week 12, Week 24, Week 36, and Week 48) and after the end of treatment (at Week 12 post-treatment and Week 24 post-treatment). The total number of injections administered will not exceed 96. | Drug | Treatment Group (Pegylated Interferon Alfa-2b) |
Primary outcome
The efficacy of patients treated with PEG-IFN-α-2b (Pegylated Interferon-α-2b) is evaluated based on HBV serological markers and HBV DNA at baseline, during follow-up, and at the follow-up endpoint.
Time frame: From enrollment to week 24 post-treatment
Subjects in the treatment group will receive PEG-IFN-α-2b (Pegylated Interferon-α-2b) treatment for a consecutive 48 weeks. Follow-up visits will be conducted during the treatment period (Weeks 4, 8, 12, 24, 36, and 48) and after treatment completion (Weeks 12 and 24 post-discontinuation), with the total number of injections not exceeding 96. The efficacy of the treatment for subjects will be mainly evaluated based on the detection results of HBV serological markers (HBsAg、HBsAb、HBeAg、HBeAb、HBcAb) and HBV DNA at time points including baseline, during follow-up, and at the follow-up endpoint.
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 17 Nov 2025.
- 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.
Yongyin Li, doctor principal investigator
Nanfang Hospital, Southern Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Peginterferon alfa-2b Injection in people with HBV and Chronic Hepatitis B Virus, run by Nanfang Hospital, Southern Medical University at 1 site in China.
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 4 inclusion and 12 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 17 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Yongyin Li (+8613826039505, yongyinli@foxmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The efficacy of patients treated with PEG-IFN-α-2b (Pegylated Interferon-α-2b) is evaluated based on HBV serological markers and HBV DNA at baseline, during follow-up, and at the follow-up endpoint. (time frame: From enrollment to week 24 post-treatment). 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 17 Nov 2025.