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

Recruitingn/aAges 18 Years - 70 YearsAllMinghui Li
NCT06696664 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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.
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What it tests

  • PEG-IFN-α
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Where

1 site
Beijing Ditan Hospital, Capital Medical University
Beijing, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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