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

Inclusion Criteria6

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 Criteria14

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.

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.