NCT07231276Not yet recruitingPhase 4
Prospective Cohort Study on PEG-IFN-α-2b in Improving Clinical Cure Rate of Pediatric Patients With Chronic Hepatitis B
Prospective Cohort Study on Pegylated Interferon Alfa-2b in Improving Clinical Cure Rate of Adolescent and Pediatric Patients With Chronic Hepatitis B Virus Infection
Source: ClinicalTrials.gov · Last updated 17 Nov 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 113 (estimated)
- First submitted
- 18 Sept 2025
- Start date
- 1 Jan 2026
- Primary completion date
- 8 Aug 2028
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Diseases
- Hepatitis B
- NCT number
- NCT07231276
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 113
- From 1 Jan 2026 to the primary completion date, 8 Aug 2028
- 1 site in 1 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.
Other illness
- Co-infection with hepatitis A virus (HAV), hepatitis C virus (HCV), hepatitis D virus (HDV), hepatitis E virus (HEV), or human immunodeficiency virus (HIV);
Lab values
- 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;
- 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 \[ULN\]);
Other
- Subjects deemed unsuitable for enrollment by the investigator(s).
Who the study is looking for
- 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).
Age in the registry: 3 years to 18 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Nanfang Hospital Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.