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

Condition(s) studied

Investigational drug(s) / intervention(s)

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

Study 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

Primary outcome measure(s)

• Clinical cure — 96 weeks
  HBsAg negative, with or without the presence of anti HBs, HBV DNA below the lower limit of detection, ALT\<lower limit of normal value
• Non clinical cure — 96 weeks
  Non clinical cure (partially effective and ineffective): HBsAg has not turned negative Partially effective: HBV DNA is below the lower limit of detection, ALT is below the lower limit of normal. Invalid: Not partially valid.

Trial sites (1)

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