Exploring genetic factors in chronic hepatitis B treatment with pegylated interferon-α

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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's running

• Beijing Ditan Hospital, Capital Medical University
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Study coordinator: Weihua Cao, Dr
• Email: weihuacaohappy@163.com
• Phone: 18811333129

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.