RECRUITINGOBSERVATIONAL

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

Exploring the Genome-wide Association Study of the Advantageous Population for Clinical Cure of Chronic Hepatitis B With Long-acting Interferon Therapy

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form form before the start of the study. Who Should NOT Join This Trial: - 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 conditions (where your immune system attacks your own body)s. - Patients who become pregnant during PEG-IFN - α treatment; - Other situations that the patient deems unsuitable for inclusion in this trial. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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.

Treatments Being Tested

DRUG

PEG-IFN-α

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

Locations (1)

Beijing Ditan Hospital, Capital Medical University

Beijing, Beijing Municipality, China