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RECRUITING
NCT06746701

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

Sponsor: Xiangya Hospital of Central South University

View on ClinicalTrials.gov

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.

Official title: 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.

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

OBSERVATIONAL

Enrollment

400

Start Date

2023-05-25

Completion Date

2029-05-25

Last Updated

2024-12-24

Healthy Volunteers

No

Conditions

Interventions

DRUG

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.

DRUG

Nucleotide Analogues

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

Locations (4)

The Third Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

Chenzhou Second People's Hospital

Chenzhou, Hunan, China

First Affiliated Hospital of Nanhua University

Hengyang, Hunan, China

Hengyang Third People's Hospital

Hengyang, Hunan, China