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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

RECRUITINGSponsored by Minghui Li
Actively Recruiting
SponsorMinghui Li
Started2024-08-01
Est. completion2026-03-31
Eligibility
Age18 Years – 70 Years

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.

Eligibility

Age: 18 Years – 70 Years
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.

Conditions2

Chronic Hepatitis bLiver Disease

Interventions1

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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