Overview

Eligibility

Design Details

Arms & Interventions

Outcome Measures

Trial Sites

Source: NCT06746701

Recruiting

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

Observational

Phase not listed

The Third Affiliated Hospital of Sun Yat-sen University

Sponsor: Xiangya Hospital of Central South University

Last Updated: December 24, 2024
Notice- Information is sourced from public registries and may not reflect real-time changes at the local site.

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.

Treatment Category

Other Drugs

Required Mutations

None

Trial Started

May 25, 2023

Last Updated by Sponsor

December 24, 2024

Estimated Completion

May 25, 2027

Contact Study

Name:LeDu Zhou, Ph.D

Email:zhould@scu.cn

Phone:17373120367

Name:Lei Fu, Ph.D

Email:fulei92@126.com

Phone:0731-84327221

Eligibility

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.

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Design Details

AllocationN/A

Intervention ModelN/A

MaskingN/A

Number to Enroll400

Arms & Interventions

Arms

Interventions

Type: N/A

Description:

Interventions:

Peg-IFNα-2b combined with NA
Nucleotide Analogues

Outcome Measures

Primary Outcome Measures

Clinical cure ratethrough 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 ratethrough study completion, an average of 24 weeks.

Secondary Outcome Measures

The decrease in HBsAg compared to baseline.through study completion, an average of 24 weeks.

HBsAg seroconversion ratethrough 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 signsthrough 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 assessmentsthrough study completion, an average of 24 weeks.

Incidence of severe acute allergic reactions occurring during treatment.through study completion, an average of 24 weeks.

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Trial Sites

This study has 4 trial sites

The Third Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, CN

Name:LeDu Zhou, Ph.D

Recruiting

Guangzhou, Guangdong, CN

The Third Affiliated Hospital of Sun Yat-sen University

Recruiting

Chenzhou, Hunan, CN

Chenzhou Second People's Hospital

Recruiting

Hengyang, Hunan, CN

First Affiliated Hospital of Nanhua University

Recruiting

Hengyang, Hunan, CN

Hengyang Third People's Hospital

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