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

Central South University

Status

Enrolling

Conditions

HBV

Treatments

Drug: Peg-IFNα-2b combined with NA

Drug: Nucleotide Analogues

Study type

Observational

Funder types

Other

Identifiers

NCT06746701

202207428

Details and patient eligibility

About

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.

Enrollment

400 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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.