Exploring the Genome-wide Association Study of the Population With Clinical Cure Advantage in the Treatment of Chronic Hepatitis B With Long-acting Interferon
Recruiting · NCT06696664 · Observational (researchers observe without assigning treatment) · Lead sponsor: Minghui Li
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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.
Where it is running
1 location listed.
- Beijing Ditan Hospital, Capital Medical University - Beijing, Beijing Municipality, China