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

Recruiting

• Conditions: HBV
• Interventions: Drug: Peg-IFNα-2b combined with NA; Drug: Nucleotide Analogues

• Registration Number: NCT06746701
• Lead Sponsor: Xiangya Hospital of Central South University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-05-25
• Status Verified: 2024-12
• Study First Submitted: 2024-12-10
• Study First Submitted QC: 2024-12-17
• Last Update Submitted: 2024-12-17
• Study First Posted: 2024-12-24
• Last Update Posted: 2024-12-24
• Primary Completion: 2027-05-25
• Study Completion: 2029-05-25

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Peg-IFNα-2b combined with NA	Peg-IFNα-2b combined with NA	-
NA monotherapy	Nucleotide Analogues	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

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