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

ConditionHBV

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18-65

SponsorXiangya Hospital of Central South University

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial population

Select chronic HBV carriers with a family history of liver cancer from each center.

Trial design

Design model

Case-control

Time perspective

Other

Treatments tested in this trial

Peg-IFNα-2b combined with NA
Drug
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
Drug
Starting from the first day of enrollment, take NA orally once a day.

Treatment groups

400 Participants

are divided into 2 treatment groups

Group A: Peg-IFNα-2b combined with NA1 intervention

Group B: NA monotherapy1 intervention

Trial outcomes

Primary outcomes

Clinical 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