Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:13 PM
Ignite Modification Date:
2025-12-24 @ 10:13 PM
NCT ID:
NCT01095835
Eligibility Criteria:
Inclusion Criteria:
* adults 18-70 years of age;
* HBeAg-negative chronic hepatitis B for \>/=6 months;
* liver disease consistent with chronic hepatitis B.
Exclusion Criteria:
* interferon-based, systemic anti-HBV, antiviral, anti-neoplastic, or immunomodulatory therapy \</=12 months before first dose of study drug;
* non-responders to previous interferon therapy;
* co-infection with hepatitis A, C or D, or with human immunodeficiency virus (HIV);
* hepatocellular cancer;
* compensated (Child A, score 6) or decompensated liver disease (Child B or C).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT01095835
Study Brief:
Protocol Section:
NCT01095835