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.

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.

Study Overview

• Status: Recruiting
• Conditions: HBV
• Intervention / Treatment: Drug: Peg-IFNα-2b combined with NA; Drug: Nucleotide Analogues

• Study Type: Observational
• Enrollment (Estimated): 400

Contacts and Locations

• Study Contact: Name: LeDu Zhou, Ph.D; Phone Number: 17373120367; Email: zhould@scu.cn
• Study Contact Backup: Name: Lei Fu, Ph.D; Phone Number: 0731-84327221; Email: fulei92@126.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China
      • Recruiting
      • The Third Affiliated Hospital of Sun Yat-Sen University
      • Contact: LeDu Zhou, Ph.D; Phone Number: 17373120367; Email: zhould@scu.cn
  • Hunan
    • Chenzhou, Hunan, China
      • Recruiting
      • Chenzhou Second People's Hospital
      • Contact: LeDu Zhou, Ph.D; Phone Number: 17373120367; Email: zhould@scu.cn
    • Hengyang, Hunan, China
      • Recruiting
      • First Affiliated Hospital of Nanhua University
      • Contact: LeDu Zhou; Phone Number: 17373120367; Email: zhould@scu.cn
    • Hengyang, Hunan, China
      • Recruiting
      • Hengyang Third People's Hospital
      • Contact: LeDu Zhou, Ph.D; Phone Number: 17373120367; Email: zhould@scu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Select chronic HBV carriers with a family history of liver cancer from each center.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Peg-IFNα-2b combined with NA	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.
NA monotherapy	Drug: Nucleotide Analogues; Starting from the first day of enrollment, take NA orally once a day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.

Secondary Outcome Measures

Outcome Measure	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.
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.

Collaborators and Investigators

• Sponsor: Xiangya Hospital of Central South University
• Investigators: Principal Investigator: LeDu Zhou, Ph.D, Xiangya Hospital of Central South University

Study record dates

Study Major Dates

• Study Start (Actual): May 25, 2023
• Primary Completion (Estimated): May 25, 2027
• Study Completion (Estimated): May 25, 2029

Study Registration Dates

• First Submitted: December 10, 2024
• First Submitted That Met QC Criteria: December 17, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 17, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: HBV; Peginterferon α-2b injection; Nucleotide Analogues
• Additional Relevant MeSH Terms: Anti-Infective Agents; Antiviral Agents; Peginterferon alfa-2b
• Other Study ID Numbers: 202207428

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No