Exploring the Genome-wide Association Study of the Population With Clinical Cure Advantage in the Treatment of Chronic Hepatitis B With Long-acting Interferon

NCT ID: NCT06696664

Last Updated: 2024-11-20

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 120 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-08-01
• Study Completion Date: 2026-03-31

Brief Summary

This study is a real-world case-control study conducted, with 120 CHB patients who received continuous treatment with PEG-IFN-α for more than 24 weeks as study subjects. Among them, the clinical cure group obtained through PEG-IFN-α treatment is the case group; The group that did not achieve clinical cure after PEG-IFN-α treatment was used as the control group, and the case group and control group were allocated cases in a 2:1 ratio. Collect blood samples from subjects as sequencing samples for candidate genes, use high-throughput sequencing technology to detect the whole genome of subjects, identify relevant genetic polymorphism that have predictive value for clinical cure of chronic hepatitis B treated with PEG-IFN-α, and establish a predictive model and calculation formula between gene polymorphism and the efficacy of PEG-IFN-α antiviral therapy.

Detailed Description

This study is a real-world case-control study conducted on 120 patients with chronic hepatitis B (CHB) who were continuously treated with pegylated interferon-α (PEG-IFN-α) for more than 24 weeks. Among them, the clinical cure group obtained through PEG-IFN-α treatment is the case group; The group that did not achieve clinical cure after PEG-IFN-α treatment was used as the control group, and the case group and control group were allocated cases in a 2:1 ratio. Collect blood samples as candidate gene sequencing samples, use high-throughput sequencing technology to detect the whole genome of the subjects, identify relevant genetic polymorphism that have predictive value for clinical cure of chronic hepatitis B with PEG-IFN-α therapy, and establish a predictive model and calculation formula between gene polymorphism and the efficacy of PEG-IFN-α antiviral therapy.

Conditions

Chronic Hepatitis B

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Case group

Case group (HBsAg negative conversion group): 120 CHB patients who achieved clinical cure after continuous treatment with PEG-IFN-α for more than 24 weeks.

PEG-IFN-α

Intervention Type: DRUG

chronic hepatitis B (CHB) who were continuously treated with pegylated interferon (PEG-IFN - α) for more than 24 weeks

Control group

Control group: 300 CHB patients who were continuously treated with PEG-IFN - α for more than 24 weeks without clinical cure.

PEG-IFN-α

Intervention Type: DRUG

chronic hepatitis B (CHB) who were continuously treated with pegylated interferon (PEG-IFN - α) for more than 24 weeks

Interventions

PEG-IFN-α

chronic hepatitis B (CHB) who were continuously treated with pegylated interferon (PEG-IFN - α) for more than 24 weeks

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 18 years old ≤ age ≤ 70 years old, Han ethnicity, gender not limited;
• According to the "Guidelines for the Prevention and Treatment of Chronic Hepatitis B (2022)", patients with HBsAg and/or HBV DNA positivity for more than 6 months and chronic inflammatory liver disease caused by persistent HBV infection are diagnosed with chronic hepatitis B (CHB);
• The patient receives subcutaneous injections of PEG-IFN-α for at least 24 consecutive weeks;
• Patients voluntarily sign an informed consent form before the start of the study.

Exclusion Criteria

• Patients with co infection of HCV, HDV, HIV, and Treponema pallidum;
• Patients with evidence of alcohol abuse, decompensated cirrhosis, liver tumors (liver cancer or AFP>100 ng/ml), or autoimmune diseases.
• Patients who become pregnant during PEG-IFN - α treatment;
• Other situations that the patient deems unsuitable for inclusion in this trial.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Minghui Li

OTHER_GOV

Sponsor Role: lead

Responsible Party

Minghui Li

Director and Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Beijing Ditan Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Weihua Cao, Dr

Role: CONTACT

weihuacaohappy@163.com

18811333129

Facility Contacts

Minghui Li, Dr

Role: primary

wuhm2000@sina.com

+8613693259096

Other Identifiers

BTP-CHB04

Identifier Type: -

Identifier Source: org_study_id