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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Peg-IFNα-2b combined with NA |
| ||
| NA monotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | through study completion, an average of 24 weeks. |
| Liver cancer incidence rate | through study completion, an average of 24 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| The decrease in HBsAg compared to baseline. | through study completion, an average of 24 weeks. | |
| HBsAg seroconversion rate | through study completion, an average of 24 weeks. | |
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Inclusion Criteria:
Exclusion Criteria:
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Select chronic HBV carriers with a family history of liver cancer from each center.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| LeDu Zhou, Ph.D | Contact | 17373120367 | zhould@scu.cn | |
| Lei Fu, Ph.D | Contact | 0731-84327221 | fulei92@126.com |
| Name | Affiliation | Role |
|---|---|---|
| LeDu Zhou, Ph.D | Xiangya Hospital of Central South University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Third Affiliated Hospital of Sun Yat-sen University | Recruiting | Guangzhou | Guangdong | China |
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| ID | Term |
|---|---|
| D012964 | Sodium |
| ID | Term |
|---|---|
| D008672 | Metals, Alkali |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D019565 | Metals, Light |
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This study is a retrospective-prospective observational study.
|
| Nucleotide Analogues | Drug | Starting from the first day of enrollment, take NA orally once a day. |
|
| 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. |
| Incidence of treatment-emergent adverse event (AE) | 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. |
| Chenzhou Second People's Hospital | Recruiting | Chenzhou | Hunan | China |
|
| First Affiliated Hospital of Nanhua University | Recruiting | Hengyang | Hunan | China |
|
| Hengyang Third People's Hospital | Recruiting | Hengyang | Hunan | China |
|
| D008670 |
| Metals |