Study on the Treatment of Hepatitis B Virus(HBV) Infected Individuals With Peginterferon α-2b Combined With NA.

NCT06746701 · tracked via the Priya Life Science China tracker

Sponsor

Xiangya Hospital of Central South University

Phase

Observational

Started

2023-05-25

Last updated

2024-12-24

Condition(s) studied

HBV

Investigational drug(s) / intervention(s)

Peg-IFNα-2b combined with NA →Nucleotide Analogues

Peg-IFNα-2b combined with NA: From baseline day 1, take NA orally once daily until the drug can be discontinued. Concurrently, combine with Peg-IFN α-2b 180μg, administered subcutaneously once a week for 48-96 weeks (if the surface antigen is not converted to negative at week 48, continue Peg-IFN α-2b treatment, but the course of treatment should not exceed 96 weeks). Discontinue Peg-IFN α-2b (while maintaining continuous oral administration of NA), and continue taking NA orally.

Nucleotide Analogues: Starting from the first day of enrollment, take NA orally once a day.

Study summary

This is a retrospective prospective, open-label, multicenter clinical study aiming to recruit 400 individuals with a family history of liver cancer to explore the clinical cure rate and the effectiveness, feasibility, and safety of PEGylated interferon α-2b combined with nucleos(t)ide analogues in treating chronic HBV carriers with a family history of liver cancer for reducing the risk of liver cancer occurrence. Patients will enrolled into Group A (Peg-IFNα-2b combined with NA treatment group) or Group B (NA monotherapy group) based on their medication choices. Each group is expected to enroll 200 patients, with all patients followed up to 240 weeks. The dosage, frequency, and duration of treatment with Peg-IFN α-2b and NA will be prescribed by the researchers according to clinical practice and standard treatment protocols.

Eligibility

Sex

ALL

Min age

18 Years

Max age

65 Years

Healthy volunteers

Inclusion Criteria: * Age18-65 years (inclusive of 18 and 65), no restriction on gender; * HBsAg positive history for at least 6 months; * Family history of liver cancer \[including first-degree and second-degree relatives; first-degree relatives are parents, children, and siblings (same parents), while second-degree relatives are uncles, aunts, grandparents, and great-grandparents; a family history of liver cancer means that one or more first-degree or second-degree relatives have had liver cancer\]; * Planning to or already receiving treatment with Peginterferon alpha-2b in combination with nucleoside (acid) analogs, or receiving nucleoside (acid) analogs treatment alone; * Negative urine or serum pregnancy test within 24 hours before the first dose (for women of childbearing age); * Willing to receive treatment and sign an informed consent form. Exclusion Criteria: * Allergy to interferon; * History of using telbivudine for antiviral treatment; * ALT(Alanine Aminotransferase) greater than 10 times the upper limit of normal, total bilirubin greater than 2 times the upper limit of normal; * Decompensated liver cirrhosis; * Neutrophil count \< 1.5 x 10\^9/L or platelet count \< 80 x 10\^9/L; * Presence of severe lesions in vital organs such as the cardiovascular, pulmonary, renal, brain, and fundus; * Those with autoimmune diseases, psychiatric disorders, poorly controlled diabetes, or thyroid dysfunction (hyperthyroidism or hypothyroidism); * Confirmed or suspected liver cancer or other malignant tumors; * Post-organ transplant or preparing for organ transplantation; * Currently using immunosuppressants; * Pregnant or planning to become pregnant within 2 years; * Alcohol or drug addicts; * HIV co-infection; * Other conditions deemed unsuitable for interferon use by the attending physician.

Primary outcome measure(s)

Clinical cure rate — through study completion, an average of 24 weeks.
The definition of a cure is: maintaining HBsAg(Hepatitis B surface antigen) negativity (with or without the appearance of anti-HBs), undetectable HBV DNA, normal liver biochemical indices, and improvement in liver tissue lesions after discontinuation of treatment.
Liver cancer incidence rate — through study completion, an average of 24 weeks.

Trial sites (4)

Facility	City	Region	Status
The Third Affiliated Hospital of Sun Yat-sen University	Guangzhou	Guangdong	Recruiting
Chenzhou Second People's Hospital	Chenzhou	Hunan	Recruiting
First Affiliated Hospital of Nanhua University	Hengyang	Hunan	Recruiting
Hengyang Third People's Hospital	Hengyang	Hunan	Recruiting

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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

Real-world Study on Liver Cancer Risk in Chronic Hepatitis B Patients With Family History of Liver Cancer Starting soon

A Real-World Study of Antiviral Therapy in Children With Chronic Hepatitis B Starting soon

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

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 NCT06746701 on ClinicalTrials.gov ↗ ← All trials in China