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

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.

Overview

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.

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.

Primary outcome measures

• Clinical cure rate [Time frame: through study completion, an average of 24 weeks.]
• Liver cancer incidence rate [Time frame: through study completion, an average of 24 weeks.]

Secondary outcome measures (7)

• 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.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Case-control

Study locations

China · 4 centers

• The Third Affiliated Hospital of Sun Yat-sen University — Guangzhou
• Chenzhou Second People's Hospital — Chenzhou
• First Affiliated Hospital of Nanhua University — Hengyang
• Hengyang Third People's Hospital — Hengyang

Identifiers

NCT: NCT06746701 · 202207428

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗