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
Minghui Li
120 participants
Aug 1, 2024
OBSERVATIONAL
Conditions
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
Inclusion Criteria4
- 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 Criteria4
- 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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Interventions
chronic hepatitis B (CHB) who were continuously treated with pegylated interferon (PEG-IFN - α) for more than 24 weeks
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06696664