Tests peginterferon alfa-2b in children and teens with chronic hepatitis B
Compares peginterferon alfa-2b with no drug treatment in young people with hepatitis B.
Plain-language title generated from the registry record
Registry title: Prospective Cohort Study on PEG-IFN-α-2b in Improving Clinical Cure Rate of Pediatric Patients With Chronic Hepatitis B
Key facts
- Where
- Guangzhou, ChinaSee the site
- Phase
- Phase 4
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 3 and 18 years old?
Source: NCT07231276, who can take part
Where in China
- Nanfang HospitalGuangzhou, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Nanfang Hospital, Southern Medical University
- Trial code
- NCT07231276
- Record updated
- 17 November 2025
- Original description
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 full original descriptionShow less
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.
Inclusion: 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).
Exclusion: 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; 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).