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.
Study Type
OBSERVATIONAL
Enrollment
400
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.
Starting from the first day of enrollment, take NA orally once a day.
The Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
RECRUITINGChenzhou Second People's Hospital
Chenzhou, Hunan, China
RECRUITINGFirst Affiliated Hospital of Nanhua University
Hengyang, Hunan, China
RECRUITINGHengyang Third People's Hospital
Hengyang, Hunan, China
RECRUITINGClinical cure rate
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.
Time frame: through study completion, an average of 24 weeks.
Liver cancer incidence rate
Time frame: through study completion, an average of 24 weeks.
The decrease in HBsAg compared to baseline.
Time frame: through study completion, an average of 24 weeks.
HBsAg seroconversion rate
Time frame: through study completion, an average of 24 weeks.
Changes of biomarkers after disease progression-related markers such as HBV DNA quantification compared to baseline.
Time frame: through study completion, an average of 24 weeks.
Incidence of abnormal and clinically relevant changes in vital signs
Time frame: through study completion, an average of 24 weeks.
Incidence of treatment-emergent adverse event (AE)
Time frame: through study completion, an average of 24 weeks.
Incidence of abnormal and clinically relevant changes in laboratory assessments
Time frame: through study completion, an average of 24 weeks.
Incidence of severe acute allergic reactions occurring during treatment.
Time frame: through study completion, an average of 24 weeks.
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