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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

• Clinical cure [Срок оценки: 96 weeks]
• Non clinical cure [Срок оценки: 96 weeks]

Вторичные конечные точки (4)

• HBV DNA turns negative [Срок оценки: 96 weeks]
• HBeAg conversion to negative [Срок оценки: 96 weeks]
• HBsAg re positivity rate [Срок оценки: 96 weeks]
• Improvement in liver function [Срок оценки: 96 weeks]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Дизайн исследования

Модель наблюдения

Случай-контроль

Центры проведения

Китай · 1 центр

• Beijing Ditan Hospital, Capital Medical University — Пекин

Идентификаторы

NCT: NCT06696664 · BTP-CHB04

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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