NCT06696664 Exploring the Genome-wide Association Study of the Population With Clinical Cure Advantage in the Treatment of Chronic Hepatitis B With Long-acting Interferon
| NCT ID | NCT06696664 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Minghui Li |
| Condition | Chronic Hepatitis B |
| Study Type | OBSERVATIONAL |
| Enrollment | 120 participants |
| Start Date | 2024-08-01 |
| Primary Completion | 2026-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 120 participants in total. It began in 2024-08-01 with a primary completion date of 2026-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06696664 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Chronic Hepatitis B. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06696664 currently recruiting?
Yes, NCT06696664 is actively recruiting participants. Contact the research team at weihuacaohappy@163.com for enrollment information.
Where is the NCT06696664 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT06696664 clinical trial?
NCT06696664 is sponsored by Minghui Li. The trial plans to enroll 120 participants.