HBV
Conditions
Keywords
Peginterferon α-2b injection, Nucleotide Analogues, HBV
Brief 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.
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.
Sponsors
Xiangya Hospital of Central South University
Study design
Observational model
CASE_CONTROL
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical cure rate | through study completion, an average of 24 weeks. | 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. |
| Liver cancer incidence rate | through study completion, an average of 24 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes of biomarkers after disease progression-related markers such as HBV DNA quantification compared to baseline. | through study completion, an average of 24 weeks. |
| Incidence of abnormal and clinically relevant changes in vital signs | through study completion, an average of 24 weeks. |
| The decrease in HBsAg compared to baseline. | through study completion, an average of 24 weeks. |
| Incidence of abnormal and clinically relevant changes in laboratory assessments | through study completion, an average of 24 weeks. |
| Incidence of severe acute allergic reactions occurring during treatment. | through study completion, an average of 24 weeks. |
| Incidence of treatment-emergent adverse event (AE) | through study completion, an average of 24 weeks. |
| HBsAg seroconversion rate | through study completion, an average of 24 weeks. |
Countries
China
Contacts
Primary ContactLeDu Zhou, Ph.D
Backup ContactLei Fu, Ph.D
Outcome results
None listed