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

RECRUITING

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

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.

NCT06746701•Xiangya Hospital of Central South University

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 65 years

Sex

ALL

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;
+4 more criteria

Locations (4)

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

Key Dates

Start Date

May 25, 2023

Primary Completion Date

May 25, 2027

Completion Date

May 25, 2029

Last Updated

December 24, 2024

Enrollment

400

ESTIMATED participants

Conditions

HBV

Interventions

Peg-IFNα-2b combined with NA

DRUG

Nucleotide Analogues

DRUG

Contacts

LeDu Zhou, Ph.D

CONTACT

17373120367 zhould@scu.cn

Lei Fu, Ph.D

CONTACT

0731-84327221 fulei92@126.com

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NCT06671093

Chronic Hep BChronic Hepatitis b+2 more

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RECRUITING

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 24, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Phase 1b, Open-label Study of Tune-401 to Assess Safety, PK and PD in Adults With Chronic Hepatitis B

Analysis of Methylomic Features and Prognostic Risk Prediction in Patients With Hepatitis B-related Acute-on-chronic Liver Failure

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