Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide
Clinical Trials in China / NCT07231276
Starting soon Phase 4

Prospective Cohort Study on PEG-IFN-α-2b in Improving Clinical Cure Rate of Pediatric Patients With Chronic Hepatitis B

NCT07231276 · tracked via the Priya Life Science China tracker
Sponsor
Nanfang Hospital, Southern Medical University
Phase
Phase 4
Started
2026-01-01
Last updated
2025-11-17

Condition(s) studied

HBVChronic Hepatitis B Virus

Investigational drug(s) / intervention(s)

Peginterferon alfa-2b Injection →

Peginterferon alfa-2b Injection: 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 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.

Eligibility

Sex
ALL
Min age
3 Years
Max age
18 Years
Healthy volunteers
No
Inclusion Criteria: * 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 Criteria: * 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: 1. Decompensated hepatitis B cirrhosis; 2. Subjects with autoimmune liver disease, metabolic liver disease, alcoholic liver disease, malignant tumor, decompensated liver disease, or a history of organ transplantation; 3. Subjects with severe neurological or psychiatric diseases; 4. Subjects with severe thyroid dysfunction, antinuclear antibody hyperactivity, or other autoimmune diseases; 5. Subjects with diabetes mellitus with poor blood glucose control; 6. Subjects with retinal or fundus lesions; 7. Subjects with severe heart disease, coronary heart disease, or cerebrovascular disease; 8. 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).

Primary outcome measure(s)

  • 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. — 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.

Trial sites (1)

FacilityCityRegionStatus
Nanfang Hospital Guangzhou Guangdong

More Nanfang Hospital, Southern Medical University trials in China

Lenvatinib Plus Tislelizumab and CapeOX as First-Line Treatment for Advanced GC/GEJC With Positive PD-L1 and Low TMEscore Recruiting
Sequential TACE-SBRT Combined With Targeted Immunotherapy for Patients With Intermediate to Advanced Liver Cancer Active, not recruiting
Umbilical Cord-derived Mesenchymal Stem Cell Exosomes on Hair Growth in Patients With Androgenetic Alopecia Active, not recruiting
Neoadjuvant Cadonilimab Plus Chemotherapy for Locally Advanced Esophagogastric Junction and Gastric Cancer Trial Starting soon
Doxepin Solution for Alleviation of Stubborn Breakthrough Pain Induced by Swallowing in Patients Receiving Radiotherapy for Nasopharyngeal Carcinoma Recruiting

Other trials for the same condition

Antiviral Therapy in Infants With HBV Infection Starting soon
Predictive Value of HBV pgRNA on Long-term Outcomes in Hepatitis B Patients Treated With Antiviral Therapy Starting soon
A Clinical Study of AHB-121 in Healthy Participants and Chronic Hepatitis B (CHB) Participants Starting soon
Real-world Study on Liver Cancer Risk in Chronic Hepatitis B Patients With Family History of Liver Cancer Starting soon
Study on the Treatment of Hepatitis B Virus(HBV) Infected Individuals With Peginterferon α-2b Combined With NA. Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07231276 on ClinicalTrials.gov ↗ ← All trials in China