RecruitingNCT06746701

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

Investigating the Clinical Cure Rate and the Risk Reduction of Hepatocellular Carcinoma in Chronic HBV Infected Individuals With a Family History of Liver Cancer Using PegIFN α-2b Combined With NA Treatment in a Real-world Study.

Sponsor

Xiangya Hospital of Central South University

Enrollment

400 participants

Start Date

May 25, 2023

Study Type

OBSERVATIONAL

Conditions

HBV

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

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study looks at the outcomes of treating chronic hepatitis B virus (HBV) infection with peginterferon alfa-2b combined with antiviral tablets (nucleoside/nucleotide analogues) in people who have a family history of liver cancer, to see if this combination reduces the long-term risk of liver cancer development. **You may be eligible if...** - You are between 18 and 65 years old - You have had a positive hepatitis B surface antigen (HBsAg) for at least 6 months - You have a family history of liver cancer (first- or second-degree relatives) - You are planning to receive or are already receiving treatment with peginterferon alfa-2b plus antiviral medication **You may NOT be eligible if...** - You are allergic to interferon - You have previously been treated with telbivudine - Your liver enzymes or bilirubin are significantly elevated - You have decompensated cirrhosis (liver failure) - You have severe heart, lung, kidney, or brain disease - You have autoimmune disease, psychiatric disorder, poorly controlled diabetes, or thyroid dysfunction - You have HIV co-infection - You are pregnant or planning pregnancy within 2 years - You have suspected or confirmed liver cancer or another malignancy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPeg-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.

DRUGNucleotide Analogues

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