Prospective Cohort Study on PEG-IFN-α-2b in Improving Clinical Cure Rate of Pediatric Patients Wi… (NCT07231276) | Clinical Trial Compass
Not Yet RecruitingPhase 4
Prospective Cohort Study on PEG-IFN-α-2b in Improving Clinical Cure Rate of Pediatric Patients With Chronic Hepatitis B
China113 participantsStarted 2026-01-01
Plain-language 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). 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.
Who can participate
Age range
3 Years – 18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Exclusion criteria
. 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;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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.
Timeframe: From enrollment to week 24 post-treatment
Trial details
NCT IDNCT07231276
SponsorNanfang Hospital, Southern Medical University