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

NCT06746701 | Recruiting

• 1 other identifier: 202207428
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 4

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.

Conditions

HBV

Keywords

Peginterferon α-2b injection; Nucleotide Analogues; HBV

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• 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.

Study Arms (2)

Peg-IFNα-2b combined with NA

Drug: Peg-IFNα-2b combined with NA

NA monotherapy

Drug: Nucleotide Analogues

Interventions

Peg-IFNα-2b combined with NA DRUG

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.

Peg-IFNα-2b combined with NA

Nucleotide Analogues DRUG

Starting from the first day of enrollment, take NA orally once a day.

NA monotherapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xiangya Hospital of Central South University: lead

Study Sites (4)

The Third Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

RECRUITING

Chenzhou Second People's Hospital

Chenzhou, Hunan, China

RECRUITING

First Affiliated Hospital of Nanhua University

Hengyang, Hunan, China

RECRUITING

Hengyang Third People's Hospital

Hengyang, Hunan, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

This study is a retrospective-prospective observational study.

MeSH Terms

Interventions

Sodium

Intervention Hierarchy (Ancestors)

Metals, Alkali; Elements; Inorganic Chemicals; Metals, Light; Metals

Study Officials

• LeDu Zhou, Ph.D

  Xiangya Hospital of Central South University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

LeDu Zhou, Ph.D

CONTACT

17373120367; zhould@scu.cn

Lei Fu, Ph.D

CONTACT

0731-84327221; fulei92@126.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2024
• First Posted: December 24, 2024
• Study Start: May 25, 2023
• Primary Completion (Estimated): May 25, 2027
• Study Completion (Estimated): May 25, 2029
• Last Updated: December 24, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (4)