Exploring genetic factors in chronic hepatitis B treatment with pegylated interferon-α
Exploring the Genome-wide Association Study of the Advantageous Population for Clinical Cure of Chronic Hepatitis B With Long-acting Interferon Therapy
This study is trying to see if certain genetic factors can help predict how well chronic hepatitis B patients will respond to treatment with pegylated interferon-α.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Beijing Municipal Administration of Hospitals Government |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT06696664 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the genetic factors that may influence the clinical cure of chronic hepatitis B (CHB) patients treated with pegylated interferon-α (PEG-IFN-α). It involves 120 CHB patients who have been on PEG-IFN-α treatment for over 24 weeks, divided into a case group (those who achieved clinical cure) and a control group (those who did not). Blood samples will be collected for high-throughput genome sequencing to identify genetic polymorphisms that could predict treatment outcomes. The goal is to establish a predictive model linking these genetic factors to the efficacy of PEG-IFN-α therapy.
Who should consider this trial
Good fit: Ideal candidates are Han ethnicity adults aged 18 to 70 with chronic hepatitis B who have been treated with PEG-IFN-α for at least 24 weeks.
Not a fit: Patients with co-infections, severe liver disease, or those who are pregnant during treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to personalized treatment strategies for chronic hepatitis B based on genetic profiles.
How similar studies have performed: While genetic studies in hepatitis B treatment are ongoing, this specific approach using PEG-IFN-α and genome-wide association is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Beijing, Beijing Municipality
- Beijing Ditan Hospital, Capital Medical University — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Study coordinator: Weihua Cao, Dr
- Email: weihuacaohappy@163.com
- Phone: 18811333129
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.