Study on the Treatment of Hepatitis B Virus(HBV) Infected Individuals With Peginterferon α-2b Combined With NA.
NCT ID: NCT06746701
Last Updated: 2024-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
400 participants
OBSERVATIONAL
2023-05-25
2029-05-25
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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CASE_CONTROL
OTHER
Study Groups
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Peg-IFNα-2b combined with NA
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.
NA monotherapy
Nucleotide Analogues
Starting from the first day of enrollment, take NA orally once a day.
Interventions
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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.
Nucleotide Analogues
Starting from the first day of enrollment, take NA orally once a day.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
65 Years
ALL
No
Sponsors
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Xiangya Hospital of Central South University
OTHER
Responsible Party
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Principal Investigators
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LeDu Zhou, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Xiangya Hospital of Central South University
Locations
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The Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
Chenzhou Second People's Hospital
Chenzhou, Hunan, China
First Affiliated Hospital of Nanhua University
Hengyang, Hunan, China
Hengyang Third People's Hospital
Hengyang, Hunan, China
Countries
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Central Contacts
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Facility Contacts
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LeDu Zhou, Ph.D
Role: primary
LeDu Zhou, Ph.D
Role: primary
LeDu Zhou
Role: primary
LeDu Zhou, Ph.D
Role: primary
Other Identifiers
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202207428
Identifier Type: -
Identifier Source: org_study_id